Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities.
Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to CRG's corporate policies and SOPs/WPDs.
Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
Provides therapeutic training and protocol training on assigned studies, as requested.
Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
Contributes to departmental process improvement initiatives.
Clinical Trial Support:
Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
Performs data review as specified in the client contract and data validation manual including review of coding lists and/or full safety data to assess for potential safety concerns.
Marketed Products Support:
Manages signal detection activities, generates aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.
Education and Experience:
MD or equivalent required. Active medical licensure preferred.
Candidates should have a combination of clinical experience and industry experience as follows:
Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years) and one of the following:
1. Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; or
2. Direct experience in safety/Pharmacovigilance (comparable to 2 years).
Knowledge, Skills and Abilities:
Therapeutic expertise across one or more medical specialty or sub-specialties
Strong decision-making, problem solving, organizational skills and analytical skills
Excellent oral and written communication skills
Working knowledge of relevant safety databases (e.g. Medra)
Flexibility to travel domestically and internationally
Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
Proficiency in basic computer applications
Fluent in spoken and written English
Excellent interpersonal, influencing and team building skills
Understanding guidelines (FDA, ICH, EMA and GCP)
Working knowledge of biostatistics, data management, and clinical operations procedures
Ability to act as a mentor/trainer to other staff within PV
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Frequently stationary for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
Additional Skills & Qualifications:
Rheumatology, Dermatology, or Neurology Board certified
3+ years Clinical drug development industry experience (CRO, Biotech, and/or Pharma) (Candidates must have held position(s) with a company within the CRO, Biotech, and/or Pharma industries)
East-coast US based
Expert LevelDiversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
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