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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:
The (Senior) Clinical Research Physician will provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.
A day in the Life:
Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute 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 trials
Real 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 early. Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead
During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquires other functions’ dedication to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD, part of Thermo Fisher Scientific internal departments performing the required tasks during all study phases
Medical 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 indications
Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
職位要求：
Education
MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Oncology patients in hospital practice.
Knowledge, Skills, Abilities
Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
Is fluent in spoken and written English
Shown understanding and experience with NDA submission process.
Shown understanding of regulatory guidelines for adverse event reporting
Strong communication & presentation skills and is a strong teammate