Global Clinical Trial Leader

This role leads execution and delivery of early-phase global clinical trials (Phase I–II), partnering with cross-functional Protocol Execution Teams to drive timelines, vendor/CRO oversight, trial documentation (TMF/CTMS), and proactive risk mitigation to ensure high-quality study outcomes. Drive and finalize cross-functional activities ensuring the quality delivery of vendor specifications, drug supply forecasting, monitoring/communication plans, Trial Master Files (TMF), and CTMS data.

Job Title: Global Clinical Trial Leader
Location: South San Francisco, CA
Type: Contract
Compensation: $90.00-$98.00/hour
Work Model: Hybrid
Hours: 40.0

Overview
Global Clinical Trial Leader supporting a pharmaceutical company in South San Francisco, CA on a hybrid schedule. This role leads execution and delivery of early-phase global clinical trials (Phase I–II), partnering with cross-functional Protocol Execution Teams to drive timelines, vendor/CRO oversight, trial documentation (TMF/CTMS), and proactive risk mitigation to ensure high-quality study outcomes.

Responsibilities

• Provide operational guidance to global cross-functional Protocol Execution Teams (PETs) across all study stages, including start-up, conduct, and close-out.
• Foster a positive work environment built on mutual respect, innovation, and accountability at both local and global project levels.
• Drive and finalize cross-functional activities ensuring the quality delivery of vendor specifications, drug supply forecasting, monitoring/communication plans, Trial Master Files (TMF), and CTMS data.
• Collaborate with cross-functional members on study plans and coordinate effective investigator meetings.
• Participate in vendor selection alongside the PETL; oversee outsourced activities to ensure CROs and vendors deliver against contracted scopes of work.
• Provide strategic input into the overall study budget and directly manage assigned vendor budgets.
• Contribute to country and site selection, assist in developing clinical trial protocols/informed consents, and provide operational input on protocol feasibility.
• Apply critical thinking to manage timelines, identify bottlenecks, and propose resolutions.
• Maintain a patient and site-centric mindset across all trial activities.
• Partner with colleagues to establish operational best practices and enhance clinical trial execution.
• Serve as a Subject Matter Expert or single point of contact for functional initiatives.
• Coach, mentor, and share expertise to support junior staff and peers.

Requirements

• Bachelor's degree or equivalent in a scientific or healthcare discipline.
• 8+ years of clinical study management experience.
• Working knowledge of GCP/ICH requirements, international regulatory guidelines, and drug development processes.
• Some travel may be necessary.
• Proven experience managing delegated aspects of global, complex Phase I and II clinical studies.
• Success in managing a diverse portfolio of vendors and CROs.
• Adept at identifying, assessing, and mitigating operational risks using data.
• Excellent communication skills, with the ability to influence and negotiate with stakeholders.
• Creative problem solver in ambiguous situations.
• Highly flexible, solution-focused, exercising good judgment on guidance seeking.
• Advocates organizational change to positively impact the business.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-
#LI-

Ref: #568-Clinical