.This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule Other Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll 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 our 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 - now and in the future.Discover Impactful Work: This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.This person is responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations.This person leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results.This person may act as a clinical/medical representative in meetings with external stakeholders (e.G.collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.G.vendors, consultants, etc.) and other external audiences as needed.A day in the Life: Provides medical content and leadership of the clinical studies Medical Monitoring of clinical studies Establish and approve scientific methods underlying the design and implementation of clinical protocols Ensure study subject safety Regularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basis Collaborate with the study executive and independent safety committee when needed Represent clinical research through membership on trial teams.Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials Interprets, summarizes and documents clinical data for regulatory documents (e.G.INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required
