Reporting to the Executive Director, Clinical Operations, the contract Clinical Trial Manager (CTM) will manage the day-to-day operational execution of global clinical trials from study start-up through closeout. The contract CTM will be responsible for coordinating study activities, managing timelines and vendors, monitoring study and site performance, and working across functions to ensure study milestones and deliverables are achieved on time and to a high standard of quality.
This is a 6- to 12-month contract assignment offering approximately 40 hours per week. The anticipated pay rate is approximately $70 per hour for candidates in the San Francisco Bay Area. Candidates who can work onsite in South San Francisco on Mondays and Tuesdays as part of the company's hybrid work model will be given preference. ADC clinical trial experience strongly preferred.
Qualified contractors should have experience that includes: - Managing day-to-day global clinical trial activities from study start-up through conduct and closeout, including timelines, milestones, enrollment, and study performance.
- Supporting protocol review, feasibility assessments, site selection and activation, and protocol amendment activities.
- Managing CROs, sites, and clinical vendors, including oversight of plans, deliverables, timelines, budgets, and quality.
- Overseeing monitoring activities, including monitoring report review, U.S. co-monitoring, site performance, protocol deviations, data queries, and follow-up of significant issues.
- Identifying operational risks and working cross-functionally to develop and implement mitigation strategies.
- Leading study team meetings and communicating study progress, risks, decisions, and action items to internal and external stakeholders.
- Ensuring study conduct and TMF quality are consistent with study protocols, ICH/GCP, applicable regulatory requirements, and inspection-readiness expectations.
- Clinical operations experience in biotechnology, pharmaceutical, or CRO environments; ADC clinical trial experience strongly preferred.
- Strong project management, communication, problem-solving, and organizational skills; proficiency with EDC, IRT, CTMS, and eTMF.
- Ability to work effectively in a small, fast-paced biotech environment.
