Clinical Trial Manager in California at Imagene Bio

The Clinical Trial Manager is responsible for the planning, execution, and oversight of clinical trials supporting the development of the company’s investigational therapies. This role manages clinical studies from start-up through closeout, ensuring trials are conducted in accordance with the study protocol, applicable regulatory requirements, Good Clinical Practice (GCP), and company quality standards.

As a key member of a small, dynamic biotech team, the Clinical Trial Manager works cross-functionally with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, and other internal and external stakeholders. The role provides hands-on operational leadership, manages CROs and other external vendors, monitors study timelines, budgets, and quality, and proactively identifies and resolves risks to study execution. The ideal candidate is a flexible, detail-oriented clinical operations professional who thrives in a fast-paced, resource-conscious environment and can balance strategic planning with direct involvement in day-to-day trial management.

· Lead operational planning and execution of assigned clinical trials, including study timelines, milestones, and operational risk assessments.

· Lead the development of informed consent forms, contribute to protocol development and review study documents, including case report forms, monitoring plans, and other essential trial materials.

· Coordinate study start-up activities, including site identification and feasibility, site selection, investigator qualification, and site activation.

· Oversee preparation and collection of regulatory and essential documents required for study initiation.

· Coordinate clinical trial submissions and documentation with Regulatory Affairs and other relevant stakeholders.

· Support development and maintenance of study-specific plans, including monitoring, risk management, vendor oversight, and communication plans.

· Lead day-to-day oversight of contract research organizations (CROs), central laboratories, imaging providers, electronic clinical systems providers, and other external vendors.

· Establish clear expectations, deliverables, timelines, and performance metrics for external service providers.

· Review vendor progress reports, identify performance gaps, and drive timely resolution of issues.

· Participate in vendor selection, qualification, contracting, and budget negotiations in collaboration with company leadership.

· Ensure vendor activities are conducted in accordance with contractual obligations, study requirements, GCP, and applicable regulations.

· Maintain effective communication and accountability across external partners while ensuring appropriate sponsor oversight.

· Oversee ongoing trial activities to ensure adherence to the protocol, study timelines, and applicable regulatory and quality requirements.

· Provide oversight of site initiation, routine monitoring, and closeout activities, including review of monitoring reports and follow-up on outstanding issues.

· Support investigator and site communications, enrollment planning, patient recruitment and retention strategies, and resolution of site-level challenges.

· Monitor study progress, enrollment, protocol deviations, data quality, and operational performance.

· Identify and escalate risks affecting participant safety, data integrity, study timelines, or budget.

· Coordinate study team meetings and ensure action items, decisions, and follow-up activities are documented and completed.

· Typically, 5+ years of experience in clinical research or clinical operations, including 2+ years of direct clinical trial management or equivalent study leadership experience.

· Experience managing clinical trials in the biotechnology, pharmaceutical, or contract research organization environment.

· Experience overseeing CROs, clinical vendors, and investigative sites.

· Working knowledge of ICH-GCP, applicable clinical trial regulations, and clinical research processes.

· Demonstrated experience managing study timelines, budgets, vendor deliverables, and operational risks.

· Experience with clinical trial documentation, TMF management, monitoring oversight, and inspection readiness.

· Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), and other clinical technology platforms.

· Strong written and verbal communication, organizational, problem-solving, and project management skills.

· Ability to work independently, prioritize competing demands, and adapt to changing business and clinical development needs.