102 jobs found in raleigh

Category: Retail Operations ID: PETCO02010 Schedule: Part-Time Location: Raleigh, NC, USA SUMMARY OF POSITION: Sell Invisible Fence® Brand solutions, services and products. Meet or exceed sales targets with in-home sales presentations, promotional work and work to develop new business within assigned regions. JOB RESPONSIBILITIES: • Sell solutions, services and products that are offered and approved through the Invisible Fence® Brand network • Meet and assess customers’ pets during in home consultations and determine their suitability for Invisible Fence® Brand solutions • Be proficient with the Sales materials, products and processes • Provide direction and support to in-store associates • Negotiate contracts with customers • Actively network with veterinarians and their offices and other influencer opportunities for referral generation • Maintain relationships and favorable contacts with current and potential customers • Completes and turns into General Manager (GM) all appropriate daily paperwork including the collection of customer payment, sales agreement contracts and daily activity sheets • Completes monthly commission report • Collaborate with the GM to formalize training material topics and materials to help bolster sales • Understand customer base, competition and market dynamics • Exceed standard customer satisfaction levels by resolving customer issues by taking personal ownership of the situation • Solicits customer referrals • Manage the vehicle maintenance schedules and keep equipment in good working condition • Participate in home shows • Keep and monitor inventory levels as necessary assigned to Pet Consultant and keep all equipment in good working condition What We Have to Offer You Base salary plus commission Company vehicle plus paid gas for all business use. Excellent Health, Dental and Vision insurance package – 70-90% company-paid. 401K Plan with 5% company match Generous Paid Holiday and Time Off Schedules – 26 paid days off in first year! Company-paid Life, STD and LTD insurances Generous annual pet product allowance Gym reimbursement Pet adoption reimbursement Educational assistance program Paid training Tools Provided Company Phone Provided Every other Saturday Off Bring your dog to work with you!! To learn more about our company, please click here: http://www.invisiblefence.com PM20 Experience Required Pet Sales PI119418113

Category: Animal Care ID: INSTA02007 Schedule: Full-Time Location: Raleigh, NC, USA For over 45 years, Invisible Fence® Brand has been keeping more than 3 million dogs and cats safe at home by providing pet owners with trusted technology, proven training procedures and total peace of mind. We pioneered the concept of electronic pet containment. The results of our efforts are impressive. We have a 98% customer satisfaction rating and a 99.5% success rating of keeping Dogs Safe at Home! If you are looking for a growing company offering a fantastic total compensation package, and LOVE DOGS and PEOPLE TOO, then this is the company for you! We are looking for serious individuals who are highly motivated, reliable and bring a positive attitude to the work force. It is also important that you have excellent communication and interpersonal skills, particularly the ability to interact effectively with our clients. Responsibilities: Install assigned Invisible Fence® Brand pet solutions each day. Setup, operate and maintain all assigned installation equipment. Maintain in good working order and cleanliness of all company vehicles and equipment assigned to Field Technician and report to General Manager (GM) is issue that require additional maintenance. Provide service for all Invisible Fence® Brand solutions. Effectively train pets to Invisible Fence® Brand solutions. Provide superior customer service by Helping design and confirm solution layouts with customer. Return calls to the office regarding any customer concerns immediately. Solicit and collect customer referrals and endorsement letters. Maintain customers’ home by providing a clean and neat installation/service and always cleaning up any messes that are made during the work being provided. Consistently deliver friendly, positive and professional service at all times including travel times to jobs to include professional driving habits. Offer and sell additional solutions to consumers. Maintain Ambassador status for Invisible Fence® Brand by actively generating referrals, leads and appointments with every customer contact. Collect all necessary paperwork and payments for all appropriate work and submit to GM in a timely manner. Maintain proper inventory and stocking of products for service vehicles. Meet and assess customer’s pets and determine their suitability for Invisible Fence® Brand solutions and report to customer and GM any potential issues. Qualifications: Valid driver's license with good record. Customer service and/or sales experience. Great communication skills. Enjoy working outdoors in all types of weather. Enjoy working with dogs and people. Must be able to lift up to 80 lbs on a regular basis. Must be able to work some Saturdays. Must be proficient in internet and email usage, and able to learn new software quickly! A high level of professionalism. Ability to solve problems and perform well under pressure and time constraints. Ability to read, write, and speak English and to be able to effectively communicate sales or service agreements with customer’s in an accurate manner. Excellent communication skills, with special emphasis on effective listening. Well-groomed and maintain continued professional appearance and demeanor. Must maintain prompt and consistent attendance to include arrival times for work on job assignments. Ability to understand customer base, competition and market dynamics. Exceed standard customer satisfaction levels. Benefits $15 per hour plus 8.5% commission Company van plus paid gas for all business use. Excellent Health, Dental and Vision insurance package – 70-90% company-paid. 401K Plan with 5% company match Generous Paid Holiday and Paid Time Off Schedules – 26 paid days off in first year! Company-paid Life, STD and LTD insurances Generous annual pet product allowance Gym reimbursement Pet adoption reimbursement Educational assistance program To learn more about our company, please click here: http://www.invisiblefence.com PM20 Qualifications Skills Required Highly Organized Novice Attention to Detail Novice Behaviors Preferred Dedicated Devoted to a task or purpose with loyalty or integrity Team Player Works well as a member of a group Experience Required 1 years: Field Installation Technician 1 years: Customer Service PI119418115

Description: Construction Superintendent Job Description: We are currently hiring a Construction Superintendent - Residential. The ideal candidate must have experience working as a Superintendent or Builder with a home building company, have a history of success in achieving customer satisfaction, and is comfortable in a production builder environment. Highly competitive and above market pay available to the right candidate. You will oversee project planning, scheduling, budgeting, and implementation. McKee Homes is a people centric company firmly based on our core focus - "Passionately Enriching your Quality of Life by Delivering an Incredible and Unique Homebuying Experience." Each employee is treated as whole person (family matters). Your efforts will be recognized. You will enjoy a fun, fair, caring, people centric environment. Opportunities for growth and contribution are numerous. PM17 .Requirements: Construction Superintendent Job Requirements: Previous experience in construction management or other related fields Familiarity with construction management software Strong leadership qualities Strong negotiation skills Deadline and detail-oriented Construction Superintendent Responsibilities: Oversee all aspects of construction project from planning to implementation Allocate resources for assigned projects Supervise onsite personnel and subcontractors Interface with project inspectors, contractors, architects, engineers, city and county officials, and clients Maintain high standards of workmanship that adhere to original plans and specifications PI119415605

Description: McKee Homes has an amazing opportunity for you! We offer multiple ways of earning income including base salary with commission, as well as commission-only as a part of our competitive commission program. First year inexperienced In-house sales agents could make anywhere from $75,000-$100,000 a year! Experienced agents potentially in the mid 100's! We offer extensive training on new home sales, our products, and processes to those with a sales background interested in new home sales. We also offer training to experienced homebuilding sales agents to help assimilate you to our high quality products and processes. McKee Homes is a people centric company firmly based on our core focus - "Passionately Enriching your Quality of Life by Delivering an Incredible and Unique Homebuying Experience." Each employee is treated as whole person (family matters). Your efforts will be recognized. You will enjoy a fun, fair, caring, people centric environment. Opportunities for growth and contribution are numerous. PM17 .Requirements: REQUIRED EDUCATION AND EXPERIENCE Minimum High School Diploma or equivalent / Bachelors Degree preferred Valid Drivers License because driving is an essential function of this position Previous sales experience preferred ESSENTIAL FUNCTIONS • Demonstrate model home, community, area, and builder story • Prepare required paperwork for each home sale and for prospective purchasers • Keep buyer updated as to construction start and completion dates and remain actively involved in the sales process through closing • Communicate properly, to the appropriate departments, any customer requests for information or service • Complete weekly traffic and other reports as necessary • Update CRM and other systems with pertinent information COMPETENCIES • Communication Proficiency • Results Driven • Organizational Skills • Initiative • Customer/Client Focus • Technical Capacity PI119415597

Description: ONLINE SALES CONSULTANT SUMMARY/OBJECTIVE Responsible for qualifying and managing leads and customer requests for new homes through online and phone contacts; maintain website, CRM, and listing information ONLINE SALES CONSULTANT ESSENTIAL FUNCTIONS Respond to all email, phone and chat leads immediately Qualify each lead based on needs Provide consistent follow-up to online leads with the goal of setting an appointment with the New Home Sales Consultants Provide information and marketing materials to leads, along with other important selling points of each community Work with each lead to determine best community and floor plan Utilize CRM on a daily basis Track and report on lead activity and sales conversion ratios Train New Home Sales Consultants on CRM, hand off process, etc. as needed Manage accurate and updated website and listings PM17 .Requirements: ONLINE SALES CONSULTANT COMPETENCIES Communication Proficiency Time and Project Management Collaboration Skills Technical Capacity Organization Relationship Management ONLINE SALES CONSULTANT SUPERVISORY RESPONSIBILITY This position has no supervisory responsibilities. ONLINE SALES CONSULTANT WORK ENVIRONMENT This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, electronic stamp machines, and online systems. ONLINE SALES CONSULTANT PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. Frequently required to sit; occasionally required to stand and walk. Occasionally required to reach with hands and arms. Frequently required to talk or hear. Occasionally required to bend, twist, or climb. Moderate concentration/intensity, which includes prolonged mental effort with limited opportunity for breaks. Average memory, taking into consideration the amount and type of information. Moderate level of complexity for decision making. Average time pressure of decision making. The noise level in the work environment is usually moderate ONLINE SALES CONSULTANT POSITION TYPE/EXPECTED HOURS OF WORK This is a full-time position. Days and hours vary between weekday, weeknight, and weekend hours as necessary ONLINE SALES CONSULTANT TRAVEL Occasional travel is required to support team in other areas. ONLINE SALES CONSULTANT REQUIRED EDUCATION AND EXPERIENCE Previous sales experience desired, but not required PI119415599

Pharmaceutical Research Associates, Inc. Information System Security Officer (ISSO) US-NC-Raleigh Job ID: 2020-62233 Type: US-Southeast # of Openings: 1 Category: Information Technology PRA Health Sciences Overview The PRA Health Sciences Cybersecurity Office seeks an Information System Security Officer (ISSO) to assist the organization in the development, management, and maintenance of the information system security processes and deliverables relating to IT system authorization. The individual will work closely with other members of our Cybersecurity and Information Technology teams to ensure the proper information is gathered, documented, and tracked over the life of the information systems assigned in order to meet the requirements of PRA and its customers. In addition, as a member of our Cybersecurity Risk Management team, this individual will assist in the assessment and management of various system-related risks typically encountered in the management of information systems in a large, global company. PRA is a leading contract research organization based in Raleigh, NC. This role is based in the corporate headquarters and reports to the Associate Director of Cybersecurity Risk Management. Responsibilities Develop and maintain System Security Plans (SSPs) for the IT systems requiring such plans, working in conjunction with business and technical system owners, as well as system administrators and relevant subject matter experts (SMEs) to ensure information is accurately documented. Participate in the system assessment and authorization (A&A) process used to plan, develop, implement, and maintain information systems at PRA. Conduct risk assessments on these systems and ensure adequate threat analysis and vulnerability scanning are performed as part of continuous monitoring. Scan results may be provided to the ISSO or may be obtained through direct scanning under the guidance of our vulnerability management team. Develop Security Assessment Report (SAR) as needed. Assist in the development of appropriate Plans of Actions and Milestones (POAMs) for assigned systems, ensuring business and technical system owners provide adequate information and agree to the proposed treatment plan(s). Track and manage these POAMs as part of routine risk management and continuous monitoring activities. Assist the organization in aligning these activities with current and prospective customer requirements, particularly with respect to the NIST Cybersecurity Framework (CSF), SP 800-171, Risk Management Framework (RMF), FedRAMP, and other various security and risk management frameworks and guidance used by our company and our customers. Provide assistance as a security control SME to various stakeholders who have business needs relating to these activities; e.g., internal audit, quality assurance, legal affairs, compliance teams, etc. Assist in the development and documentation of the processes associated with these above activities, as well as appropriate training materials needed to adequately inform key stakeholders of their roles and responsibilities in these processes. Assist in other risk assessment activities managed by the Cybersecurity Risk Management team, as needed to support its other business functions, including but not limited to support of third-party risk management and assessments, cyber program assessments, risk metrics and reporting, risk management process assurance and improvement, global security awareness and training, and risk intelligence/communications. Qualifications Desired Qualifications Prior experience working as an ISSO for US Federal Government systems in accordance with associated NIST standards and guidance relating to implementation and assessment of security controls and the authorization of information systems, as well as the authoring and management of system security plans, system assessment reports, and the management of associated POAMs. Experience working with the business system owners to negotiate proper and adequate documentation of existing security controls and desired future implementations of controls. Ability to effectively perform information security duties within a risk-based security management framework. A practical understanding of the differences between risk-based and compliance-based approaches to managing and securing information systems is key to the role. Working technical knowledge of industry best practices and commonly used frameworks & standards (e.g., NIST, COSO, SOC/SSAE18, COBIT, ISO 27001-2,) and various regulations pertaining to information security, cyber risk management, compliance, and data privacy (e.g., SOX, GDPR, HIPAA, GxP). Possess broad understanding of threats, risks, and controls pertaining to technical, management, and operations security controls, system development lifecycle, application security, business continuity, disaster recovery, data center controls, cloud computing, and data privacy. Broad knowledge of typical controls used to treat various risks is highly desirable, as is the ability to recognize and provide alternative approaches to risk treatment, including appropriate compensating controls. We prefer a candidate with one or more of the following certifications: CAP, CCSP, Cloud+, GSLC, Security +, CASP, CISSP, or CISM. Minimum Requirements Bachelor's degree in Computer Science, Information Systems, Cybersecurity, Enterprise Risk Management or related field or equivalent experience 3 years of information systems security, cybersecurity, compliance or related experience or combined equivalent education, training, and experience. Excellent written and verbal communication skills, as well as attention to detail. No additional need for technical writing assistance. Read, write and speak fluent English, with strong documentation and organizational skills. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PI119399179

Pharmaceutical Research Associates, Inc. Vice President, Sales West Region US-Remote Job ID: 2020-62135 Type: US-Northwest # of Openings: 1 Category: Consulting Services PRA Health Sciences Overview Vice President, Sales – West Region Company Description Symphony Health, a PRA Health Sciences Company, is a leading provider of high-value data, analytics, and technology solutions for biopharmaceutical manufacturers, healthcare providers, and payers. The company helps clients understand disease incidence, prevalence, progression, treatment and influences along the patient and prescriber journeys by connecting and integrating a broad set of primary and secondary data, and providing health research, analytics and consulting expertise. Symphony Health derived data improves health management decisions, and helps clients drive revenue growth while providing critical insights on how to effectively adapt to the changing healthcare ecosystem. The VP, Sales – West Region manages the region’s sales team to exceed revenue objectives, sales goals, and customer satisfaction. The VP leads a team of National Account Directors in establishing and maintaining positive client relationships and is responsible for fulfilling the sales and revenue targets assigned to the region on a quarterly and annual basis. Responsibilities The VP is directly responsible for: Revenue Attainment – achieving quarterly revenue objectives for the territory and individual clients; overseeing sales strategy and approach to achieve success Sales – achieving sales objectives across the portfolio of data services and Consulting & Solutions groups (e.g., Brand Analytics, Managed Markets, Technology/Health Data Services, Commercial Effectiveness) Account Planning – defining comprehensive account plans with deep knowledge of the customers (pipeline, strategy, organization, competitive dynamics, etc.); aligning Symphony Health offerings and client needs; ensuring successful execution Account Management – building strong, valued and long-term relationships with clients; ensuring client satisfaction with Symphony Health services Sales Administration – managing pipeline, forecasting, planning to achieve sales and revenue targets. In addition, the VP is a member of the commercial leadership team with overall responsibility for achieving the company’s revenue targets through successful execution of the company’s commercial strategy. Fulfilling these broad responsibilities requires a detailed understanding of the client, our company, our products and services, as well as an understanding of the processes and methods to fulfill client expectations and meet sales goals.   Qualifications Sales leadership - Demonstrated sales leadership and ability to manage a team of senior level sales resources. Demonstrated ability to develop sales strategies in a complex and highly competitive marketplace. Commercial pharmaceutical experience – detailed knowledge of core commercial processes, data and analytics in the pharmaceutical marketplace. Ideally, deep knowledge of the assigned set of clients and key players in the client organization. Solution selling – ability to lead a matrixed team to bring together Symphony Health’s offerings and services in innovative ways to address client needs. Strong sales and account management skills – proven record of client retention and growth in life sciences accounts. Matrix management – proven ability to effectively work in matrix organization. The successful VP will establish positive working relationship with peers in other regions and in the Consulting & Solutions teams. Negotiation skills – resource is responsible for successful negotiation of master services agreements and related contracts. Financial acumen - understand revenue recognition rules and impact of sales strategy on the business. Strong administrative skills – effectively manage pipeline and forecast revenue; establish approach to exceed revenue goals and successfully execute the plan. Organizational skills - organizing and managing the direction of sales and account management teams. Leadership skills – Demonstrated leadership and ability to motivate the team to think creatively, be innovative, focus on the needs of the client in balance with the needs of the business and overall effectively manage individual members of the team. Education – The ideal candidate will have at least a Bachelor’s degree in business, sales or marketing or equivalent. An advanced degree in business is highly desirable. Experience – The ideal candidate will have 5-10 years of experience in sales leadership in companies that provide data, analytics and related services to pharmaceutical and/or life science clients. Location – The ideal candidate will reside in Chicago, Phoenix or California   Travel Requirements In general, travel is required at least 50% of the time. The above statements are intended to describe the general nature and level of work being performed by most people assigned to this job. They’re not intended to be an exhaustive list of all duties and responsibilities and requirements. Symphony Health is an Equal Opportunity Employer. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119399194

Pharmaceutical Research Associates, Inc. Local Trial Manager - Early Development (Oncology) US-Remote Job ID: 2020-62134 Type: US-Southeast # of Openings: 1 Category: Clinical Trial Management Janssen Overview We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Who are we? We Are PRA. We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Responsibilities What will you be doing? Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Local Trial Manager is responsible for the successful management and execution of study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements. Key Tasks Include (But Not Limited To): Managing the local team to meet recruitment targets The efficient management of local vendors Timely review of trip reports submitted by Site Managers Targeted and effective study team training Preparation for audits Development of local study tools and procedures Proactive risk management and budget forecasting Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators Some on-site monitoring of assigned sites Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project Qualifications What do you need to have? A minimum of a 4-year Bachelor’s degree or relevant clinical experience is required Minimum 4 or more years of pharmaceutical and/or clinical trial experience is preferred. Experience with clinical trial management is required Experience in Early Development & Clinical Pharmacology clinical preferred Solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills. Willingness to travel with occasional/regular overnight stay away from home depending on the region. Flexible mindset and ability to work at a fast pace within small exploratory study teams. Ability to work on multiple trials in parallel in different disease areas. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119399209

Pharmaceutical Research Associates, Inc. Local Trial Manager - Early Development (Oncology) US-Remote Job ID: 2020-62133 Type: US-Southeast # of Openings: 1 Category: Clinical Trial Management Janssen Overview We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Who are we? We Are PRA. We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Responsibilities What will you be doing? Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Local Trial Manager is responsible for the successful management and execution of study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements. Key Tasks Include (But Not Limited To): Managing the local team to meet recruitment targets The efficient management of local vendors Timely review of trip reports submitted by Site Managers Targeted and effective study team training Preparation for audits Development of local study tools and procedures Proactive risk management and budget forecasting Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators Some on-site monitoring of assigned sites Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project Qualifications What do you need to have? A minimum of a 4-year Bachelor’s degree or relevant clinical experience is required Minimum 4 or more years of pharmaceutical and/or clinical trial experience is preferred. Experience with clinical trial management is required Experience in Early Development & Clinical Pharmacology clinical preferred Solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills. Willingness to travel with occasional/regular overnight stay away from home depending on the region. Flexible mindset and ability to work at a fast pace within small exploratory study teams. Ability to work on multiple trials in parallel in different disease areas. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119399224

Pharmaceutical Research Associates, Inc. Local Trial Manager - Early Development (Oncology) US-Remote Job ID: 2020-62132 Type: US-Southeast # of Openings: 1 Category: Clinical Trial Management Janssen Overview We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Who are we? We Are PRA. We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. Responsibilities What will you be doing? Working outsourced and fully dedicated to one of our global pharmaceutical clients, the Local Trial Manager is responsible for the successful management and execution of study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements. Key Tasks Include (But Not Limited To): Managing the local team to meet recruitment targets The efficient management of local vendors Timely review of trip reports submitted by Site Managers Targeted and effective study team training Preparation for audits Development of local study tools and procedures Proactive risk management and budget forecasting Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators Some on-site monitoring of assigned sites Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project Qualifications What do you need to have? A minimum of a 4-year Bachelor’s degree or relevant clinical experience is required Minimum 4 or more years of pharmaceutical and/or clinical trial experience is preferred. Experience with clinical trial management is required Experience in Early Development & Clinical Pharmacology clinical preferred Solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills. Willingness to travel with occasional/regular overnight stay away from home depending on the region. Flexible mindset and ability to work at a fast pace within small exploratory study teams. Ability to work on multiple trials in parallel in different disease areas. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119399241

Allscripts Allscripts' policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for North American based positions with Allscripts must be legally authorized to work in the United States or Canada. Verification of employment eligibility will be required as a condition of hire. From a "VEVRAA Federal Contractor" We request Priority Referral of Protected Veterans. Intern NE US-NC-Raleigh Job ID: 2020-23912 Type: Intern # of Openings: 1 Category: Information Technology Raleigh, NC Overview Welcome to Allscripts! Our Mission is to be the most trusted provider of innovative solutions that empower all stakeholders across the healthcare continuum to deliver world-class outcomes. Our Vision is a Connected Community of Health that spans continents and borders. With the largest community of clients in healthcare, Allscripts is able to deliver an integrated platform of clinical, financial, connectivity and information solutions to facilitate enhanced collaboration and exchange of critical patient information. Allscripts is looking to hire an intern for our identity and access management team to provide support and assistance for the IAM projects and initiatives for a for 12 week internship over the summer 2020. Responsibilities This intern would be working on key IAM and security projects including support, analysis, documentation, and project coordination and execution. Works with other IAM team members, product teams, and vendor representatives on projects, installations, moves, changes, troubleshooting, documentation and servicing. Responsibilities include: Learn the decision support application & business surrounding it Learn/support analysis of issues related to our IAM systems and supporting infrastructure including but not limited to: Active Directory configuration and management including security groups, GPOs, trusts, and more Active Directory monitoring IAM tools and systems for authentication and directory synchronization with hybrid cloud environments Configuration deployment and management using PowerShell scripting and GPOs Working closely with the IAM security engineers and security teams to develop and enforce use of policies, standards, and IT Controls for Active Directory Participate in benchmarking, installation, upgrade, configuration, deployment and testing activity for the identity management system and IAM tools Project coordination Understand an issue, document it and work with a team to resolve it Support/lead productive meetings Qualifications Academic and Professional Qualifications: On track for a Bachelor's degree in IT, Computer Science or a related discipline 3.0 GPA preferred Experience: Good organizational skills Experience with Microsoft Office Suite (Word, Power-Point, Excel) Strong communication skills - written & verbal Computer skills Ability to provide a high level of customer service Ability to function in an ambiguous environment Quick learner Travel Requirements: None Working Arrangements: Work is performed in a standard office environment with minimal exposure to health or safety hazards At Allscripts, our greatest strength comes from bringing together talented people with diverse perspectives to support the technology needs of 180,000 physicians, 1,500 hospitals and 10,000 post-acute organizations across the globe. Allscripts offers a comprehensive compensation and benefits package, including holidays, vacation, medical, dental, and vision insurance, company paid life insurance and retirement savings. Allscripts’ PI119398775

Allscripts Allscripts' policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for North American based positions with Allscripts must be legally authorized to work in the United States or Canada. Verification of employment eligibility will be required as a condition of hire. From a "VEVRAA Federal Contractor" We request Priority Referral of Protected Veterans. MS Associate Service Desk Analyst US-NC-Raleigh Job ID: 2020-24211 Type: Regular Full-Time # of Openings: 1 Category: Information Technology Raleigh, NC Overview Welcome to Allscripts! Our Mission is to be the most trusted provider of innovative solutions that empower all stakeholders across the healthcare continuum to deliver world-class outcomes. Our Vision is a Connected Community of Health that spans continents and borders. With the largest community of clients in healthcare, Allscripts is able to deliver an integrated platform of clinical, financial, connectivity and information solutions to facilitate enhanced collaboration and exchange of critical patient information. The primary purpose of this role is to provide service desk support to client users and any other duties as needed. Responsibilities Acts as initial point of contact for user support calls to the IT Service Desk such that all calls are logged correctly and promptly allocated appropriately within the IT team. Provides first-line technical support when handling calls, in order to provide time-of-call resolution to less complex calls whenever possible. Provides an ad-hoc service to users of all computer systems, troubleshooting and resolving systems problems Carries out a prescribed program of system performance monitoring, measurement, management, and capacity planning for computer systems, to support a pro-active approach to meeting changing system demands. Assist in the maintainence of the Service Desk Knowledge Base. Qualifications Academic and Professional Qualifications: BA or BS degree preferred or other relevant combination of training and experience. Experience: 0- 2 years entry level to moderate experience in providing service desk support preferred Travel Requirements: May require local travel May require other travel for business needs Working Arrangements: May be required to work off hour shifts or be assigned to an on-call rotation. 24/7 Support Work is performed in a standard office environment with minimal exposure to health or safety hazards At Allscripts, our greatest strength comes from bringing together talented people with diverse perspectives to support the technology needs of 180,000 physicians, 1,500 hospitals and 10,000 post-acute organizations across the globe. Allscripts offers a competitive total rewards package, including holidays, vacation, and medical, disability and life insurance. Allscripts’ PI119398723

Pharmaceutical Research Associates, Inc. Sr Medical Writer- Home Based- Oncology US-Remote Job ID: 2020-62266 Type: Canada-West # of Openings: 1 Category: Medical Writing Merck Overview Do you want to watch clinical development change, or do you want to be the one to shape it? Because we’re hoping you’re here for the latter. Who are we? We Are PRA. We are 17,000+ employees strong, operating in more than 80 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting lifesaving drugs into the hands those who need them most. Who are you? You are a Medical Writer who researches, writes, and edits clinical documents by applying functional expertise and clinical drug development knowledge. Applies a wide range of therapeutic expertise and clinical drug development knowledge to the development of drugs, biologics, devices and/or other products for human use in developing individual clinical study protocols, clinical plan outlines, drug development programs, clinical study reports, manuscripts, investigator brochures, and sections of regulatory submission documents. Also provides therapeutic training to external clients and internal PRA staff. Responsibilities Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation. - Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams (either internally or externally). - Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation. - Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. Works collaboratively with colleagues across functions to achieve results. - Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members . - May participate in orientation and coaching of junior team members or contractor writers. - May participate in initiatives to improve medical writing processes and standards. Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD, protocols and various amendments) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines. - Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD, protocols and various amendments) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines. - Participate actively in medical writing and cross-functional project teams. - Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management. - Excellent oral (including presentation) and written communication, and project management skills. - Awareness of pharmaceutical industry needs beyond clinical development. Qualifications Previous oncology experience preferred in pharma or biotech setting, biomarker or pk experience a plus. Available full-time (40 hours/week) Willing to work core business hours, be online and accessible to sponsor and colleagues, and comply with online learning required on regular basis by sponsor 100% remote-based position, must have fully-operable home-office, already setup, in US or CAN Technologically adept at learning new sponsor processes and document management systems Demonstrated experience leading and managing a clinical regulatory document through the various stages of development through to completion/submission. Able to manage 2-3 documents, in various stages of development, at a time Participate actively in medical writing and cross-functional project teams. Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management. Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development Bachelor’s Degree in the Life Sciences with 8 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR MS Degree in the Life Sciences with 4 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR PhD in the Life Sciences with 3 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119357584

Pharmaceutical Research Associates, Inc. Sr Medical Writer- Home Based- Oncology US-Remote Job ID: 2020-62265 Type: US # of Openings: 1 Category: Medical Writing Merck Overview Do you want to watch clinical development change, or do you want to be the one to shape it? Because we’re hoping you’re here for the latter. Who are we? We Are PRA. We are 17,000+ employees strong, operating in more than 80 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting lifesaving drugs into the hands those who need them most. Who are you? You are a Medical Writer who researches, writes, and edits clinical documents by applying functional expertise and clinical drug development knowledge. Applies a wide range of therapeutic expertise and clinical drug development knowledge to the development of drugs, biologics, devices and/or other products for human use in developing individual clinical study protocols, clinical plan outlines, drug development programs, clinical study reports, manuscripts, investigator brochures, and sections of regulatory submission documents. Also provides therapeutic training to external clients and internal PRA staff. Responsibilities Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation. - Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams (either internally or externally). - Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations. Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation. - Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings. Works collaboratively with colleagues across functions to achieve results. - Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members . - May participate in orientation and coaching of junior team members or contractor writers. - May participate in initiatives to improve medical writing processes and standards. Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD, protocols and various amendments) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines. - Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD, protocols and various amendments) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines. - Participate actively in medical writing and cross-functional project teams. - Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management. - Excellent oral (including presentation) and written communication, and project management skills. - Awareness of pharmaceutical industry needs beyond clinical development. Qualifications Previous oncology experience preferred in pharma or biotech setting, biomarker or pk experience a plus. Available full-time (40 hours/week) Willing to work core business hours, be online and accessible to sponsor and colleagues, and comply with online learning required on regular basis by sponsor 100% remote-based position, must have fully-operable home-office, already setup, in US or CAN Technologically adept at learning new sponsor processes and document management systems Demonstrated experience leading and managing a clinical regulatory document through the various stages of development through to completion/submission. Able to manage 2-3 documents, in various stages of development, at a time Participate actively in medical writing and cross-functional project teams. Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management. Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development Bachelor’s Degree in the Life Sciences with 8 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR MS Degree in the Life Sciences with 4 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR PhD in the Life Sciences with 3 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119357624

Allscripts Allscripts' policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for North American based positions with Allscripts must be legally authorized to work in the United States or Canada. Verification of employment eligibility will be required as a condition of hire. From a "VEVRAA Federal Contractor" We request Priority Referral of Protected Veterans. Systems Engineer US-NC-Raleigh Job ID: 2020-24201 Type: Regular Full-Time # of Openings: 1 Category: Client Service/Support Raleigh, NC Overview Welcome to Allscripts! Our Mission is to be the most trusted provider of innovative solutions that empower all stakeholders across the healthcare continuum to deliver world class outcomes. Our Vision is a Connected Community of Health that spans continents and borders. With the largest community of clients in healthcare, Allscripts is able to deliver an integrated platform of clinical, financial, connectivity and information solutions to facilitate enhanced collaboration and exchange of critical patient information. The primary purpose of this role is to install, implement, configure, upgrade, and optimize the performance of application systems and databases required to operate Allscripts software Development and QA environments. Responsibilities Establish, manage and maintain the Systems Development Environments, Upgrades, and Assigned Tasks that meet agreed functional requirements and customer expectations Consistent efforts to deliver as per agreed scope and excel the deliveries from “completeness” and “correctness” point of view Customer focus and closer alignment with the customers’ business objectives Ensure enough reviews have happened (Peer, Stakeholders) and all review comments have been closed / incorporated before delivery of any artefacts Keep all stakeholders informed for scope creep and get their consensus Ensure efforts to continually improve domain knowledge Infrastructure System Development Environments, Upgrades, and Assigned Task delivered within estimates and according to agreed schedule/within Target Level of Agreement Ensure every team member knows the schedule and plan Consistent efforts for delivering as per agreed schedule / plan and excelling within that Keep all stakeholders informed in a timely manner about slippages / delays and arrive with the plan to achieve the set goals on time Infrastructure System Development Environments, Upgrades, and Assigned Task delivered with defined quality standards along with minimal amount of downtime disruptions, number of cases of poor analysis or design resulting into defects and re-work Ensure the quality of the deliverables as per the defined defects standards and excelling within that Identify the common causes of the defects, prioritize them and systematically remove them so that they do not reoccur in further development work Efforts to reduce the overall defect injection rate (DIR) Contribution towards the team synergy / influcence team to achieve goals Document issues with resolutions and share with team members to improve team productivity Provide data to generate team performance metrics Knowledge transfer with other team members to improve overall team education level Take complete ownership for the assigned task and timely inform the progress of the project / task to all stakeholders Adherence to the defined global Infrastructure standards Take initiative and drives to bring to logical conclusion; Proactive Approach Provide accurate and timely information and escalates when there are issues Actively participate in the project meetings and make valuable contribution Qualifications Academic and professional qualifications: Successful completion of a Bachelor’s Degree or relevant technical experience Experience: Typically requires 2 - 5 years of experience. Detailed technical knowledge is dependent on the specific Allscripts product Development Center requirements Travel requirements: As needed based upon project requirements Working arrangements: Work is performed in a standard office environment with minimal exposure to health or safety hazards At Allscripts, our greatest strength comes from bringing together talented people with diverse perspectives to support the technology needs of 180,000 physicians, 1,500 hospitals and 10,000 post-acute organizations across the globe. Allscripts offers a comprehensive compensation and benefits package, including holidays, vacation, medical, dental, and vision insurance, company paid life insurance and retirement savings. Allscripts PI119357183

Pharmaceutical Research Associates, Inc. Local Trial Manager - Early Development (Non Oncology) US-Remote Job ID: 2020-62241 Type: US-Southeast # of Openings: 1 Category: Clinical Trial Management Janssen Overview What will you be doing? Working outsourced and fully dedicated to one of our global pharmacuetical client, the Local Trial Manager is responsible for the successful management and execution of study activities at a country level. Collaborating with the wider global study team, the Local Trial Manager leads the local team of Site Managers and Clinical Trial Assistants in order to deliver quality data and trial documents that are compliant with protocol, ICH-GCP guidelines, Standard Operating Procedures and regulatory requirements. Key Tasks Include (But Not Limited To): Managing the local team to meet recruitment targets The efficient management of local vendors Timely review of trip reports submitted by Site Managers Targeted and effective study team training Prepartion for audits Development of local study tools and procedures Proactive risk management and budget forecasting Accompanying Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators Some on-site monitoring of assigned sites Managing studies from feasibility through to database lock and close-out, the Local Trial Manager acts as the key local manager throughout the lifecycle of the project Responsibilities What do you need to have? Qualifications: A minimum of a 4-year Bachelor’s degree or relevant clinical experience is required Minimum 4 or more years of pharmaceutical and/or clinical trial experience is preferred. Experience with clinical trial management is required Experience in Early Development & Clinical Pharmacology clinical preferred Solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills. Willingness to travel with occasional/regular overnight stay away from home depending on the region. Flexible mindset and ability to work at a fast pace within small exploratory study teams. Ability to work on multiple trials in parallel in different disease areas. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. Qualifications PI119315587

Pharmaceutical Research Associates, Inc. Sr Clinical Trial Transparency Associate US-Remote Job ID: 2020-61770 Type: US-Southeast # of Openings: 1 Category: Medical Writing Takeda Overview The Clinical Trial Transparency function is responsible for clinical trial disclosure and data sharing activities. Executes registration and results disclosure and data sharing activities in accordance with sponsor requirements and international regulations. Participates on project teams to provide guidance on public disclosure and data sharing processes and requirements, including regulatory requirements for content and format. Responsibilities • Provides subject matter expertise on public disclosure of clinical trials and point of contact for disclosure queries, client audits and special projects. • Proposes and manages activities that support evolving strategy for clinical trial data sharing. • Supports sponsor in the development and implementation of redaction of documents and generation of redaction justification tables. Supports sponsor-specific, regulatory document-sharing policies and other document/data access regulations or publication requirements as needed. • Provides oversight during the review, preparation and submission of clinical trial data sharing documents. • Creates and updates data collection tools to comply with applicable registration and results posting and data sharing requirements. • Develops and delivers training programs on registration disclosure and data sharing requirements and processes. • Engages scientists to review protocol information to ensure accurate information for public disclosure. Prepares disclosure requirements based on country disclosure regulations and sponsor policy. Enters initial protocol information on relevant internal and external websites and makes updates throughout the study through results submission. • Updates registries with changes in ongoing clinical trial status to include recruitment status, protocol amendments, site updates, and milestone dates. Communicates registration on results to relevant stakeholders. Archives registration and results post-documentation. • Generates logs regarding current study and provides information to other functional areas (Clinical Operations, Regulatory Affairs) to support work processes and ensures deadlines are known and output complies with applicable laws. Participates in/leads the evaluation of clinical trial protocols and amendments and applies knowledge of disclosure requirements to develop overall disclosure decision guidance. • Coordinates registration/results disclosure/data sharing submissions. • Oversees maintenance of registration/results disclosure and websites/portals. • Consults with government agencies to resolve submission queries. • Audits publicly disclosed information to ensure information is updated appropriately and is in compliance with applicable regulations. • Participates in industry committees to develop strategy, best practices and methodologies to clinical trial data transparency and to align with industry standards. • Manages the redaction of documents and generation of redaction justification tables, if applicable, to support Regulatory Policies and other document/data access regulations or publication requirements as needed. • Manages redacted document postings and submissions, as applicable Qualifications In-depth knowledge of scientific methodology • In-depth knowledge of applicable regulations • In-depth computer and spreadsheet development skills • Excellent written and oral communication skills Problems are differing but related. Solutions are not readily apparent. Undertakes analysis and investigation to identify and define problems. Anticipates future issues. Work is done independently Bachelor’s degree in relevant field of study. Master’s degree preferred. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119315626

Pharmaceutical Research Associates, Inc. Sr Medical Writer- Home Based US-Remote Job ID: 2020-62235 Type: US # of Openings: 1 Category: Medical Writing PRA Health Sciences Overview Researches, writes and edits clinical reports, summarizing statistical data from clinical studies, writes clinical study protocols, clinical plan outlines and sections of regulatory submission documents by applying therapeutic expertise and clinical drug development knowledge and relevant experience to the development of drugs, biologics, devices and or other products for human use. Responsibilities Acts as a Lead medical writer on a program, numerous individual studies, or other projects at a simple to complex level. Acts as Lead medical writer on simple to complex submissions projects. Provides leads for Business Development opportunities. Qualifications Substantial experience in pharmaceutical or CRO industry developing pharmaceutical drugs for human use required e.g. non-clinical science, medical related writing, protocol writing, writing for regulatory submissions, clinical trials management, monitoring, or as an investigator or sub-investigator for clinical trials Substantial experience writing clinical study reports, other regulatory submission documents, poster presentations, and manuscripts for publication in a scientific journal required Experience using computerized systems (PC-Windows, and MS Office) required Knowledge of regulatory agency requirements for protocols and regulatory submissions in the host country required Direct or indirect experience interacting with FDA or host country regulatory agency required Demonstrated project leadership skills required Read, write and speak English; fluent in host country language required In addition to: experience complex science or medical related writing experience required An advanced degree (M.S., PharmD, Ph.D.) from an accredited institution in science or a health-related field, or equivalent international education preferred. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119291125

Pharmaceutical Research Associates, Inc. Contracts Specialist US-NC-Raleigh Job ID: 2020-62224 Type: US-Southeast # of Openings: 1 Category: Contracts Administration PRA Health Sciences Overview The Contracts Specialist will work as a member of an international team of attorneys and paraprofessionals responsible for providing legal advice and counsel to the business. Primary duties for this position will involve assisting legal counsel with the drafting and negotiation of agreements with PRA’s clients, vendors, and subcontractors. The position and will work closely with various functional departments (i.e., project management, finance, operations), to ensure the timely and accurate execution of agreements to support PRA’s Early Development clinical units. The Contract Specialist is able to perform in a fast-paced environment, able to create and reset priorities as the need arises, identify and raise issues before they become critical, and adjust quickly to the changes of a dynamic organization Responsibilities Ensures the successful negotiation and on-going management of legal agreements to support PRA’s business units, primarily including Early Development Services. These may include confidentially agreements, sponsor Master Agreements, task orders, amendments/change orders, start up agreements, letters of intent, etc. Works cross functionally with Clinical Operations, Finance, Proposals, Project Management, and other departments in support of timely study start up for the conduct of clinical trials by ensuring contracts are executed accurately and on schedule. This includes accurate tracking and forecasting of contract execution timelines. Collaborates with Legal counsel to partner with other compliance departments to ensure country specific laws and regulations are followed to minimize risk in clinical trials. Ensures all relevant SOPs are followed and approvals documented during the lifecycle of the contract negotiation. Communicates and explains legal/ budgetary issues to internal and external parties per department guidelines. Reviews and evaluates client requested contract changes and based upon department guidelines escalates deviations as appropriate. In partnership with functional manager, evaluates priorities and quickly readjusts priorities with the changing needs of business and the client. Identifies and proactively raises issues to functional manager or legal counsel, as appropriate, prior to their becoming critical or creates risk. Appraises contracts for completeness and accuracy and ensures adherence to department guidelines Creates and maintains files for each contract. Tracks contract status in PRA’s database in a timely and accurate manner and ensures that status updates are fully descriptive. Generates ideas and solutions to improve requested contract/budget changes while appropriately partnering with Functional Manager and/or legal counsel feedback and review. Qualifications Minimum Qualifications: Read write and speak fluent English; fluent in host country language required. 1-2 years’ Experience with contracts. Bachelor’s Degree or international equivalent required Preferred: Three or more years’ experience in relevant areas involving contracts, negotiation or sales One or more years’ experience at Sponsor or CRO. Working knowledge of pharmaceutical drug development Familiarity with working in service industry or project mgmt. exp. JD or advanced degree PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119291160

Pharmaceutical Research Associates, Inc. Clinical Research Associate / Independent Drug Monitor - Early Development - Any Location near Hub (Home-based) US-Remote Job ID: 2020-62217 Type: US # of Openings: 1 Category: Clinical Monitoring Janssen Overview C alling ALL Experienced Clinical Research Associates – Read On, Join the Movement We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA. Who are we? We Are PRA. We are 17,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting life saving drugs into the hands of those who need them most. What’s in it for you in the long term? We promote from within – We provide a career not a job. Culture – There is nothing like it. We have many former PRA employees returning every single month. Tools and Technology – Leading the industry with time saving, intuitive smart technology to help predict trends, anticipate needs and eliminate the need for multiple data entry. Security – We are growing and we are dedicated to having you grow with us. Mentorship and Training – Our structure provides support for your growth and development as well as questions that arise while on a study at all times. Work/Life Balance – It's real; we value it. Our strategic solutions and full service models offer you choices for finding a career that includes time for your personal life. Salary/ Benefits- We are committed to providing our employees with a competitive salary and benefits package with yearly merit and performance reviews. Responsibilities The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. This role will focus on Early Development Clinical Research Studies (Phases 1-2) Qualifications Education: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required Skills: Read, write and speak fluent English; fluent in host country language required. 2+ years of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug Clinical research experience Knowledge of ICH and local regulatory authority regulations regarding drug Experience in monitoring all trial components (PSSV to COV) Ability to travel as needed (greater than 50%) 3+ years of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug PREFERRED Phase I experience highly preferred ; Immunology experience is ideal as well. All therapeutic experience is welcome including but not limited to: Oncology, Hematology, Respiratory, Cardiovascular, Pain, CNS, Infectious Disease, Metabolism, Vaccines, Transplant and Ophthalmology To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PI119291178