Clinical Study Start Up Lead
Dawar Consulting•South San Francisco, CA
•Onsite
About The Position
Our client, a world leader in diagnostics and biotechnology, is looking for a "Clinical Study Start Up Lead" based out of South San Francisco, CA. This role leads country-level start-up strategy, regulatory submissions, and site activation while ensuring alignment with global timelines and standards. You will collaborate with cross-functional teams, CROs, and regulatory bodies to enable seamless clinical trial execution.
Requirements
- Degree in Life Sciences (Bachelor’s required; advanced degree preferred)
- 2–6+ years of experience in clinical trial start-up / clinical operations
- Strong knowledge of regulatory submissions and study start-up processes
- Experience with clinical systems (Veeva Vault, CTIS, RIM, etc.)
- Experience working with CROs and external vendors
- Strong communication, stakeholder management, and collaboration
- Excellent organizational, analytical, and problem-solving skills
- Ability to manage multiple priorities in a global, matrixed environment
- Detail-oriented with a focus on compliance and timelines
Responsibilities
- Lead country start-up strategy and execution for clinical trials
- Oversee site activation, regulatory submissions, and amendments
- Ensure compliance with ICH-GCP, EU CTR, and local regulations
- Manage ICF processes, site documentation, and trial materials
- Coordinate with CROs, investigators, and regulatory authorities
- Drive process improvements, automation, and standardization
- Manage budgets, contracts, and payment oversight
- Support cross-functional alignment with global and regional teams
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
