Clinical Research Director
hace 1 semana
Company Overview: Thermo Fisher Scientific is a leading global biotechnology company that enables 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.
Job Summary: The Associate Medical Director will provide medical support and guidance for clinical trials and safety evaluation within the PPD Pharmacovigilance department. This role involves providing medical leadership to study teams, creating clinical trial protocols, reviewing and approving study protocols and amendments, and ensuring medical validity of each individual primary endpoint as well as study subject safety.
About the Role: As a Medical Director at Thermo Fisher Scientific, you will be responsible for real-time medical monitoring of clinical studies, identifying medical issues early on, and collaborating with the Global Medical Indication Lead to proactively address customer concerns and correct issues. You will also serve as the chief liaison between sponsors and internal departments, ensuring seamless communication and collaboration throughout all study phases.
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), protocol deviation decisions and other clinical documents as required
- Ensure medical validity of each individual primary endpoint as well as study subject safety in real-time medical monitoring of clinical studies
- Pro-actively address customer concerns and correct issues in consultation with the Global Medical Indication Lead
- Serve as the chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases
Requirements:
- Bachelor's degree in medicine or a related field
- At least 5 years of experience in clinical trials or pharmacovigilance
- Strong knowledge of regulatory requirements and industry standards
- Excellent communication and leadership skills
What We Offer: At Thermo Fisher Scientific, we offer a competitive salary range of $120,000 - $180,000 per year, depending on experience. Our benefits package includes health insurance, retirement savings plan, paid time off, and opportunities for professional growth and development. We are an equal opportunity employer and welcome applications from diverse candidates.
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