Role Overview
The Clinical Trials Manager plays a central role in the coordination and oversight of company-sponsored clinical studies. This position ensures the integrity of trial execution by managing study documentation, supporting clinical sites, and maintaining compliance with protocols and regulatory standards. The individual will work closely with internal teams and external partners to advance the development of novel immunotherapies.
Key Responsibilities
- Support the planning and implementation of clinical trials, including the development and revision of essential study documents such as informed consent forms, case report forms, and operational manuals
- Collaborate with clinical sites to ensure proper protocol understanding, safety reporting, and adherence to study requirements
- Facilitate site recruitment, initiation, monitoring, and close-out activities, including coordination of site payments
- Lead training sessions for site personnel and internal staff, particularly during protocol updates or staff onboarding
- Coordinate with regulatory affairs to maintain current regulatory submissions and documentation
- Organize and moderate meetings including DSMB calls, investigator teleconferences, and study team updates
- Track and summarize patient-level data including treatment progress, response, and survival outcomes
- Prepare regular clinical trial status reports for internal stakeholders
- Ensure compliance with company SOPs and escalate any ambiguities in procedures
Qualifications
- Bachelor’s degree in a biological science or related field
- Minimum of five years of experience in clinical research or a comparable role
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
- Strong written and verbal communication abilities
- Highly organized with the ability to manage multiple tasks efficiently
- Familiarity with standard operating procedures and a commitment to following documented processes
Work Environment
This is an onsite position based in Southern California. The role operates within a collaborative, science-driven culture focused on advancing next-generation cancer therapies through immune system modulation. The organization emphasizes innovation, cross-functional engagement, and professional growth opportunities for team members.
