Clinical Trial Manager

Job Description

Job Description

Summary

Reporting to the Sr. Director of Clinical Operations, the Clinical Trials Manager is responsible for overseeing and executing the operational aspects of one or more clinical studies from protocol development through database lock. This role ensures the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations and guidelines governing clinical trials. The Clinical Trials Manager provides oversight of third-party vendors and expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables.

Location

San Diego – onsite / hybrid

Responsibilities

• Assist with third-party vendor training on protocols and practices. Coordinate logistics of product readiness with sites and internally. Work cross-functionally with manufacturing, quality assurance, and supply chain management to ensure site training, product delivery, and supply management for readiness prior to patient treatment.
• Develop and maintain strong working relationships with third-party vendors, investigators, and study staff.
• Ensure studies are conducted according to the study protocol, SOPs, and ICH / GCP regulations.
• Ensure timely responses to queries and monitor discrepancies.
• Manage the accountability and reconciliation process for investigational products.
• Oversee the performance of third-party vendors, including co-monitoring, to ensure compliance with study protocols; identify concerns and escalate as necessary.
• Perform clinical data review and generate queries as needed.
• Conduct initial reviews of vendor invoices for accuracy.
• Plan and conduct investigator meetings as directed.
• Review key study quality metrics and determine appropriate actions in collaboration with the study team.
• Review and approve investigational product release packages.
• Track and report on current study progress, including site activation, patient enrollment, monitoring visits, and data submission backlogs.
• Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals, and electronic case report forms.
• Participate in planning quality assurance activities and coordinate the resolution of audit findings.
• Ensure clinical trial documentation is audit-ready; review monitoring visit reports for quality and issue resolution; assist in planning regulatory or ethics committee activities as appropriate.
• Collaborate with cross-functional teams (e.g., Medical Monitor, Regulatory Affairs, vendors, and site staff).
• Prepare and / or review study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, etc.).
• Manage clinical monitoring activities, ensuring compliance with ICH / GCP and applicable regulations, including resolution of any site or study-level issues.
• Participate in the selection, training, and evaluation of study personnel to ensure efficient operation of the function.

Requirements