Sr Clinical Trials Manager
$157,590–$203,940 year
HybridFoster City, California, United States
Job Summary
Lead assigned clinical studies within a program, including Study Management Team leadership, by developing, implementing, and overseeing study plans, timelines, logistics, budgets, and resourcing. Ensure studies are delivered on time, within budget, and in alignment with quality, protocol, SOP, and regulatory requirements while identifying risks and driving mitigation strategies. Manage CRO and vendor selection, oversight, deliverable management, and relationships, partnering with cross-functional stakeholders to align on objectives and priorities. Provide guidance, training, and direction to internal team members, CROs, vendors, and investigators, mentoring less experienced colleagues and contributing to process improvement initiatives. This hybrid role requires three days on-site (Tues-Thurs) and full-cycle study management expertise.
Required Qualifications
- BA/BS with 6+ years of relevant clinical or related life sciences experience
- MA/MS with 4+ years of relevant clinical or related life sciences experience
- Comprehensive knowledge of FDA, EMA, other applicable national regulations, ICH guidelines, and GCP requirements governing clinical studies
- Ability to travel as needed
Desired Qualifications
- Advanced degree such as MA/MS, PharmD, or PhD in a life sciences or related field
- Experience leading clinical studies and cross-functional project teams
- Demonstrated ability to lead teams, coach, and mentor less experienced colleagues
- Clear, concise communication skills and strong interpersonal effectiveness
- Proven ability to work successfully in a team-oriented, highly matrixed environment
- Strong knowledge of full-cycle study management, from start-up through close-out
- Advanced knowledge of study management best practices and tools, with demonstrated ability to improve study efficiency and effectiveness
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