Clinical Trial Manager

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.

Reporting to the Head of Clinical Operations, the Clinical Trial Manager will be accountable for the day-to-day operational oversight of a Natural History Study (NHS), which serves as the control arm for an ongoing pivotal trial. This individual will support all phases of the trial lifecycle - from start-up through conduct and close-out - ensuring adherence to protocol, SOPs, GCP, and applicable regulatory requirements.

This is a hands-on, execution-heavy role within a lean team where the CTM will manage CROs and vendors, maintain oversight of essential clinical documents and systems, and ensure smooth study execution. The ideal candidate is proactive, detail-oriented, and able to flex between strategic trial management and operational tasks to keep the study on track.

KEY RESPONSIBILITIES:  

Trial Management & Oversight

• Provide day-to-day management of the NHS trial, ensuring operational continuity and high-quality execution.
• Monitor and manage study timelines, deliverables, and milestones; escalate risks and delays proactively.
• Support development and maintenance of study documentation including operational plans, trial charters, and the Trial Oversight Plan.
• Contribute to protocol and amendment reviews and regulatory submissions.
• Support Risk-Based Quality Management (RBQM) planning and implementation.

Vendor & CRO Management

• Serve as the primary point of contact for CROs and study vendors, ensuring alignment on study deliverables.
• Participate in review and finalization of the Monitoring Plan and provide oversight of monitoring activities.
• Oversee Trial Master File (TMF) setup and ongoing quality control in collaboration with the vendor.
• Track receipt and accuracy of site regulatory documents, ensuring packages are complete and compliant.
• Attend Site Initiation Visits (SIVs) and document visit activities and outcomes.
• Operational Support & Execution
• Upload and manage contract documents in the contract management system (Ironclad).
• Ensure clinical documents and correspondence are organized, filed, and audit-ready.
• Perform light data review tasks as needed, primarily for completeness and consistency (not deep analysis).
• Collaborate with the Start-Up team on site activation and regulatory review processes.
• Track and resolve protocol deviations, KPIs/KQIs, and other operational issues.
• Participate in inspection readiness and audit support activities.

Cross-Functional Collaboration

• Facilitate Study Execution Team (SET) meetings, managing agendas, documenting discussions, and tracking action items.
• Partner with clinical investigators, site staff, and internal stakeholders to meet study goals.
• Support ex-US operational planning and CRO/vendor oversight as international study components evolve.

EDUCATION & PROFESSIONAL EXPERIENCE:

• Bachelor’s or Master’s degree in life sciences or related field (or equivalent experience).
• 3–5+ years of clinical trial management experience, preferably in a sponsor environment.
• Strong working knowledge of GCP, SOPs, and clinical trial operations best practices.
• Demonstrated experience overseeing CROs, vendors, and external partners.
• Comfort with hands-on operational responsibilities including document management, TMF oversight, and contract system uploads.
• Experience with non-interventional, RWE, or natural history studies is a plus.
• Proactive, adaptable, and able to work independently within a lean and fast-paced team environment.
• Excellent written, verbal, and cross-functional communication skills.
• Familiarity with systems such as EDC and contract management platforms (e.g., Ironclad) is preferred.

The salary range for this position is $145,000 - $170,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.