At Thermo Fisher Scientific, youâll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on â now and in the future.
Provides medical oversight of clinical trials to ensure company SOPs, client directives, goodÂ clinical practice, and regulatory requirements are followed. Attends and presents at investigatorÂ and sponsor meetings, provides medical consultation to clients, investigators and project teamÂ members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products, ICSR and periodic safety reports ( PBRER, PSUR, DSUR) as well as other client deliverablesÂ ( labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
â¢ Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICHÂ guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to clientÂ SOPs/directives and project specific WPDs for assigned projects. Adheres to CRGâs corporateÂ policies and SOPs/WPDs.
â¢ Provides medical consultation to team members and answer all study related medical questions.Â Communicates clearly with associates and clients, maintaining an open line of communication toÂ ensure all procedures are followed appropriately.
â¢ Provides therapeutic training and protocol training on assigned studies, as
â¢ Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDAÂ report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensureÂ that the medical content is accurate and complete.
â¢ Contributes to departmental process improvement initiatives.
Clinical Trial Support:
â¢ Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status,Â evaluation of prescribed concomitant medication for protocol restrictions, and un-blindingÂ requests) of clinical studies.
â¢ Discusses all medical concerns with principal investigators and clients ( discussionÂ regarding interpretation of inclusion/exclusion criteria) raised during the course of a study,Â using proper medical judgment in the interpretation and decision making with regard to clinicalÂ situations as they relate to the investigational study.
â¢ Provides medical review of adverse events of special interest, serious adverse
events and clinical outcomes events reported by study sites.
â¢ Performs data review as specified in the client contract and data validation manual includingÂ review of coding listings and/or full safety data to assess for potential safety concerns.
Marketed Products Support:
â¢ Manages signal detection activities, generates aggregate reports, contributes to label updates,Â
supports dossier maintenance and risk management activities.
â¢ Medically reviews adverse event and serious adverse event data from all sources(solicited, spontaneous, literature, etc.) as contracted.
Develops solutions to highly complex and unique issues that impact and addressÂ future concepts, products or technologies.
Having broad expertise or unique knowledge in Pediatrics or Internal Medicine with Infectious Disease and/or Rare Disease experience.
Education and Experience:
MD or equivalent required. Active medical licensure preferred.
Knowledge, Skills and Abilities:
â¢ Therapeutic expertise across one or more medical speciality or sub-specialities
â¢ Strong decision-making, problem solving, organizational skills and analytical skills
â¢ Excellent oral and written communication skills
â¢ Working knowledge of relevant safety databases ( Medra)
â¢ Flexibility to travel domestically and internationally
â¢ Ability to work independently, analyze work with attention to detail, process and prioritizeÂ sensitive complex information
â¢ Proficiency in basic computer applications
â¢ Fluent in spoken and written English
â¢ Excellent interpersonal, influencing and team building skills
â¢ Understanding guidelines (FDA, ICH, EMA and GCP)
â¢ Working knowledge of biostatistics, data management, and clinical operations procedures
â¢ Ability to act as a mentor/trainer to other staff within PV
No management responsibility
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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