Medical Director
hace 3 semanas
Medical Director Job Summary
At Thermo Fisher Scientific, we are seeking a highly skilled Medical Director to provide medical support and advice for clinical trials and safety evaluation within our PPD Pharmacovigilance department. As a key member of our team, you will be responsible for providing medical leadership to study teams, creating clinical trial protocols, and ensuring the medical validity of each individual primary endpoint as well as study subject safety.
Key Responsibilities:
- Provide medical leadership to study teams, including creating clinical trial protocols and implementing the latest scientific information.
- Contribute to site selection, review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and other clinical documents as required for the conduct of clinical trials.
- Ensure medical validity of each individual primary endpoint as well as study subject safety.
- Pro-actively address customer concerns and correct issues in consultation with the Global Medical Indication Lead.
- Serve as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases.
- Deliver protocol specific lab procedures presentations and demonstrations during investigator meetings.
- Control, handle, and follow day-to-day activities during the course of the clinical trial to resolve any issues and answer queries.
- Interact with investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable.
- Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP.
Requirements:
- Medical degree and relevant experience in clinical trials.
- Strong knowledge of clinical trial protocols, GCP, and SOPs.
- Excellent communication and leadership skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
About Thermo Fisher Scientific:
Thermo Fisher Scientific is a leading provider of scientific instrumentation, software, and services. We enable our customers to make the world healthier, cleaner, and safer by providing innovative solutions for life sciences research, clinical diagnostics, and analytical instrumentation.
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