Clinical Trial Manager

Role Summary

Clinical Trial Manager responsible for strategic implementation and execution of clinical trials from start-up to close-out, overseeing CROs, vendors, and sites, and ensuring deliverables meet regulatory requirements, GCP guidelines, and internal SOPs. Reports to Director of Clinical Operations and contributes to trial strategy and operational delivery in a fast-paced biotech environment.

Responsibilities

• Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs.
• Ensure inspection readiness by maintaining comprehensive study documentation and files.
• Organize and lead study and departmental meetings, including minute-taking and document archiving.
• Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings).
• Ensure team compliance with study-specific training and perform TMF reviews for completeness.
• Support clinical sites in audit and inspection preparation.
• Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements.
• Monitor subject and site activity/metrics and perform quality checks across study components.
• Proactively identify, troubleshoot, and escalate issues impacting deliverables.
• Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation.
• Collaborate with CROs to ensure timely collection and archiving of TMF documents.
• Partner with regulatory affairs on essential document submissions.
• Support study close-out activities including TMF and drug reconciliation and CSR readiness.
• Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads.
• Participate in process improvement and quality initiatives related to study execution.
• Other duties as deemed necessary.

Qualifications

• Required: Bachelor's degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered.
• Required: Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out.
• Preferred: Global clinical trial management experience, especially in the EU.
• Required: Strong working knowledge of ICH/GCP regulations.
• Required: Proficiency with electronic systems such as eTMF, CTMS, EDC, etc.
• Required: Ability to work independently and thrive in a collaborative team environment.
• Required: Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset.
• Required: Excellent interpersonal, written, and verbal communication skills.
• Required: Proficiency in MS Office and comfort with technology.
• Required: Minimal travel required (0 to 5%).

Education

• Bachelor's degree (as noted in Qualifications)

Additional Requirements

• Work location: On site (San Diego, CA)
• Work Authorization: United States (Required)