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About the Role
Support the execution and delivery of global Phase I and II clinical trials within Research and Early Development (RED) by partnering with cross-functional teams to ensure operational excellence and regulatory compliance.
Responsibilities
- Provide operational leadership to global cross-functional Protocol Execution Teams across study start-up, conduct, and close-out.
- Drive delivery of trial deliverables including vendor specifications, drug supply forecasting, monitoring plans, TMF, and CTMS documentation.
- Collaborate with stakeholders on study planning, protocol feasibility, site selection, and investigator meetings.
- Manage CROs and vendors to ensure performance aligns with scope, timelines, quality, and budget.
- Contribute to study budget planning and oversee assigned vendor budgets.
- Identify operational risks, develop mitigation strategies, and manage study timelines.
- Support process improvement initiatives and clinical operations best practices.
- Mentor junior team members and serve as a subject matter expert.
Requirements
- 8+ years of clinical study management experience in pharmaceutical, biotech, or CRO industry.
- Experience supporting global Phase I and/or Phase II clinical trials.
- Strong vendor and CRO management experience.
- Working knowledge of GCP, ICH guidelines, international regulations, and the drug development process.
- Some travel may be required.
Skills
- Clinical study management
- Vendor management
- CRO management
- GCP/ICH compliance
- Study budget planning
- Risk management
- Protocol execution
Location
- South San Francisco, CA
Work Type
- Hybrid
- Long Term Contract
Experience Level
- 8+ years
Education Level
- Bachelor’s degree in scientific or healthcare-related discipline preferred
Salary/Compensations
- $90/hr on W2
Benefits
- Medical
- Dental
- Vision
- Paid Sick leave
- 401K
About the Company
- World leader in biotechnology and life sciences.