Clinical Trial Manager, Clinical Operations

Job Type: Full-time
Location: San Francisco Bay Area

Position Summary

A clinical-stage biotechnology company is seeking a passionate, creative, and dedicated Clinical Trial Manager (CTM) to join its Clinical Operations team.

The CTM will support the day-to-day management and execution of one or more clinical trials in accordance with study protocols, standard operating procedures, Good Clinical Practice guidelines, and applicable regulatory requirements.

Working under the oversight of senior Clinical Operations leadership, this individual will help drive the completion of key study deliverables while maintaining high standards for data quality, compliance, and operational execution. The CTM will proactively identify, communicate, and resolve study-related operational issues and contribute to process-improvement initiatives as needed.

General Responsibilities

• Support clinical trial execution in compliance with study protocols, ICH-GCP guidelines, internal procedures, and applicable regulations.

• Manage operational aspects of one or more clinical studies, including study metrics, timelines, documentation, and study-specific meetings.

• Contribute to and coordinate the review of clinical documents, including protocols, informed consent forms, case report forms, study plans, investigator brochures, and clinical study reports.

• Coordinate the review of clinical data listings with internal cross-functional stakeholders.

• Train investigators, study coordinators, and site personnel on operational study requirements, as needed.

• Support vendor selection, contracting, and study setup activities, including review of scopes of work.

• Oversee external vendors, which may include central laboratories, imaging providers, specialty laboratories, CROs, and other clinical service providers.

• Clearly communicate expectations to vendors, monitor performance, hold partners accountable to timelines, and verify quality metrics.

• Provide guidance, direction, and oversight to Clinical Research Associates.

• Monitor clinical site performance, enrollment, data quality, and overall study conduct.

• Identify risks to study timelines or execution, propose mitigation plans, and implement solutions in partnership with cross-functional stakeholders and Clinical Operations leadership.

• Establish and maintain strong working relationships with investigators, clinical sites, and site personnel.

• Review monitoring reports and assist with the coordination of data management activities.

• Provide oversight of Trial Master File maintenance and support ongoing inspection readiness.

• Mentor and oversee Clinical Trial Associates, as appropriate.

• Participate in the development and improvement of Clinical Operations processes, systems, and procedures.

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related field with at least five years of relevant clinical research experience.

• Master’s degree, PharmD, PhD, or another advanced degree with at least three years of relevant clinical research experience may also be considered.

• Previous clinical trial or Clinical Operations experience within a biotechnology or pharmaceutical company is required.

• Prior oncology clinical trial experience is required.

• Strong knowledge of FDA, EMA, or other applicable regulatory requirements, ICH guidelines, and Good Clinical Practice.

• Demonstrated clinical study management and operational execution skills.

• Experience overseeing CROs, vendors, clinical sites, and monitoring activities.

• Strong written and verbal communication skills.

• Excellent organizational skills with the ability to prioritize multiple tasks of varying complexity.

• Demonstrated problem-solving, conflict-resolution, leadership, and team-building capabilities.

• Ability to work effectively in a fast-paced biotechnology environment while managing competing priorities.

• Proficiency with Microsoft Word, Excel, and PowerPoint.