Sr. Manager, Clinical Site Operations (CRA Oversight)

Sr. Manager, Clinical Site Operations (CRA Oversight)

Work Location: San Mateo County, California

Summary:

The Sr. Manager, Clinical Site Operations (CRA Oversight) is responsible for leading and mentoring a team of Clinical Research Associates, overseeing site-level clinical operations for assigned protocols, and ensuring high-quality execution of clinical trials. This role manages site strategy, selection, activation, performance, and close-out, while ensuring compliance with regulatory requirements and clinical trial protocols.

Responsibilities:

• Lead and mentor a team of Clinical Research Associates, providing guidance and ensuring consistent, high-quality execution of site management activities.
• Develop and implement site identification, feasibility, and selection strategies, including the creation and maintenance of feasibility tools and criteria.
• Oversee site management, monitor study performance, and ensure adherence to timelines, quality standards, and regulatory requirements.
• Drive site activation plans, manage startup deliverables, and ensure sites are trained and ready for study initiation and subject enrollment.
• Monitor site performance using dashboards and KPIs, address underperformance, and implement remediation or escalation plans as needed.
• Conduct monitoring visits, review monitoring deliverables, and ensure compliance with protocols, ICH GCP guidelines, and local regulations.
• Support inspection readiness, manage protocol deviations, and facilitate audits and follow-up actions to maintain study quality and compliance.
• Collaborate with cross-functional teams, address operational challenges, and provide operational expertise and updates on study progress and risks.

Qualifications:

• Bachelor's degree in a life sciences or health-related field required.
• 8+ years of clinical trial experience, including study monitoring; experience with laboratory developed tests (LDTs) or in vitro diagnostic devices strongly preferred.
• 3-5 years of personnel management experience.
• Proven success in multi-site management.
• Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.
• Ability to travel up to 60% within the United States, sometimes on short notice, and manage travel logistics effectively.
• Proficiency in Microsoft Office and clinical trial management systems (CTMS) required.
• CCRA/CCRP certification is desired.

Published Category: Clinical Operations & Development