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 (Bachelors required; advanced degree preferred)
  
• 26 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

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