Job DescriptionAt 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:The (Associate) Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.A day in the Life:Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific informationContribute to site selection, involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions, and other clinical documents as required for the conduct of clinical trialsReal-time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified earlyPro-active customer concern and correction of issues in consultation with the Global Medical Indication LeadDuring the initial review of the protocol, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendmentsAcquire other functions' dedication to close gaps and address issues timely and effectivelyServe as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phasesEducate Investigator sites by delivering a protocol-specific lab procedures presentation and demonstration during an investigator meetingControl, handle, and follow day-to-day activities during the course of the clinical trial to resolve any issues and answer queriesMedical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indicationsEnsure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCPClosely collaborate with the cross-functional study team members in order for medical risks, issues, and results to be clear to all involved partiesEducationMD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Cardiology patients in hospital practiceBoard certified in CardiologyKnowledge, Skills, AbilitiesExperience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine is critically importantIs fluent in spoken and written EnglishShown understanding and experience with NDA submission processShown understanding of regulatory guidelines for adverse event reportingStrong communication & presentation skills and is a strong teammateOur Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. 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. Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.Job SummaryJob number: R-01235279Date posted: 2024-03-06Profession: Clinical ResearchEmployment type: Full time #J-18808-Ljbffr