What are the responsibilities and job description for the Clinical Trial Manager, Clinical Operations (Early-Phase) position at Latigo Bio?
Reporting to the Senior Director, Clinical Operations, the Clinical Trial Manager (CTM) will be responsible for the day-to-day management and execution of assigned early-phase clinical trials, including vendor selection, study startup, subject recruitment, study conduct, and study close-out. The ideal candidate will have previous experience managing Phase 1 and clinical pharmacology studies, possess strong communication and project management skills, and be able to work effectively in a fast-paced environment.
Candidates should be local to Thousand Oaks, CA or the San Francisco Bay area.
Primary responsibilities include (but are not limited to):
- Manage all aspects of clinical study execution, including day-to-day management of CROs, laboratory vendors, clinical site, and other service providers as required. Responsible for delivery of milestones in accordance with established project timelines.
- Ensure clinical studies are conducted in compliance with SOPs, ICH/GCP guidelines, and FDA regulations. Ensure quality of clinical execution and trial data.
- Provide operational input into the development of clinical study protocols, informed consent forms, case report forms, and other study-level documents.
- Develop study plans, operational manuals, site training materials, and other study tools.
- Manage vendor accruals reporting, review and approve invoices, and oversee administration of investigator grants.
- Participate in vendor identification and selection, including input to RFPs and vendor budgets.
- Ensure selection of qualified investigators and sites.
- Provide site, CRO, and vendor training.
- Perform co-monitoring and sponsor oversight visits, as needed.
- Review and negotiate investigator site budgets and contracts.
- Ensure the proper set up and maintenance of the Trial Master File (TMF), including periodic review.
- Initiate and maintain any locally required clinical trial registries (e.g., clinicaltrials.gov).
- Proactively identify, communicate, and remediate study issues.
- Accurately track key study activities (eg., IRB approval, investigational product shipment, site activation, patient recruitment, patient status, data collection, data review, etc.) and maintain study metrics for routine reporting to the internal project team and leadership.
- Participate in review of department SOPs.
- Up to 20% travel may be required, consistent with project needs.
Minimum Requirements:
- Bachelor’s Degree in life sciences
- 5 years relevant industry experience
- Proficient knowledge of ICH GCP, CFR, and other applicable regulatory requirements for clinical trial conduct.
- Prior experience managing Phase 1 and/or clinical pharmacology studies
- Prior experience with vendor management
- Demonstrated critical thinking, problem solving, and negotiation skill
- Demonstrated ability to successfully work in cross-functional project teams with an emphasis on teamwork, collaboration, and communication
- Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines
