Clinical Study Start Up Lead

Clinical Study Start Up Lead

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. Job Duration: Long Term Contract (Possibility Of Extension) Pay Rate: $90/hr on W2

We are seeking a Clinical Study Start-Up professional to drive the efficient and compliant initiation of clinical trials. 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.

Key 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

Qualifications:

• 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

Key Skills:

• 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

If interested, please send us your updated resume at View email address on click.appcast.io / View email address on click.appcast.io