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Clinical Trials Manager
3 months ago
Responsibilities:
- Amazing opportunity for a Clinical Trials Manager in the Foster City CA area. Hybrid role.
- Responsible for the global execution of Phase I-IV clinical trials across all company therapeutic areas.
- Ensures all company clinical trials adhere to SOPs, company policies, and regulatory guidelines for high-quality data supporting product registration and commercialization.
- Collaborates with cross-functional teams including Biomarker Sciences, Clinical Pharmacology, and more.
- Manages components of clinical studies and oversees biomarker and bioanalytical vendors.
- Reviews study protocols, contributes to process development, and participates in special projects.
- Key contact for biomarker and bioanalytical operations, both internally and externally.
- Participates in multiple clinical study teams and coordinates operational activities related to biological specimen collection and analysis.
- Manages sample quality, vendor relationships, budget evaluation, and operational challenges.
- Establishes strong cross-functional relationships and leads efficient study biomarker strategies.
- Organizes operational meetings, maintains databases, reviews relevant documents, and supports project priorities.
- Contributes to RFP development, vendor selection, optimization of project processes, and compliance with regulations.
- Facilitates project meetings, authors study documents, presents at meetings, and leads study report preparations.
- Identifies and resolves operational issues to ensure study execution aligns with protocols, budgets, and timelines.
- Complies with established practices, policies, and regulatory requirements.
Experience:
- PharmD/PhD with 2 years of relevant clinical experience in Life Sciences.
- MA/MS with 3 years of relevant clinical experience in Life Sciences.
- BA/BS/RN with 5 years of relevant clinical experience in Life Sciences.
- Demonstrated ability to learn quickly and adapt to change effectively.
- Capable of managing full-cycle study components, knowledgeable in study management best practices and regulations.
- Familiar with FDA, EMA, ICH guidelines, GCP, and medical/scientific terminology.
- Experienced in overseeing external vendors.
