The Clinical Trial Manager (CTM) reports to the Senior Director of Clinical Operations and is responsible for executing and managing multiple aspects of an assigned clinical trial.
Key CTM activities include CRO vendor management, managing site recruitment activities and subject enrollment, overseeing site monitoring activity, communicating key study information to both internal and external teams, and contributing to key clinical documents. This role will also collaborate with project managers internally and at vendors to ensure study deliverables are met.
Required skills include logical thinking, ability to prioritize, “can-do” attitude, and the ability to adapt quickly to changing conditions. The CTM possesses strong communication skills and has experience working in a fast-paced environment within the biotech/pharmaceutical industry.
- Manage day-to-day clinical operations activities at CRO vendor, including start-up, maintenance, and closeout.
- Monitor the conduct and assess the progress of assigned clinical trials to ensure compliance with ICH GCP, health authority regulations and internal SOPs.
- Oversee conduct of site evaluation, site initiation, routine monitoring, and closeout visits.
- Supervise site activities at CRO partners, including ICF review, FAQ development, and timeline management.
- Author or contribute to key clinical operations documents (e.g., plans, worksheets, and study tools).
- Review electronic case report forms (eCRFs) and associated user acceptance testing (UAT).
- Develop and maintain protocol-specific processes and reference materials.
- Manage site recruitment and subject enrollment activities, including tracking and reporting associated screening details and metrics.
- Execute monitoring plans and ensure adequate support for monitoring and investigative site management activities.
- Collaborate with project management on key clinical development timelines and milestones, enrollment projections, and data delivery strategies.
- CRA monitoring strategy, ensuring regulatory compliance and on-time data delivery.
- Track project related tasks to ensure successful completion of project deliverables within required timeframes.
- Communicate study progress and team performance metrics.
- Partner with Technical Operations to ensure investigative site compliance with operational requirements related to apheresis collection, investigational product handling, and specimen management.
- Facilitate collaborative relationships with investigative site personnel, and CRO counterparts.
- Develop training and presentation materials in support of clinical trial activities.
- Train internal and external team members, as well as investigative site staff, on key clinical trial topics.
- Independently address complex data management and clinical operations issues.
- Review study data listings and electronic data capture systems for overall quality, consistency, completeness, and protocol compliance.
- Ensure protocol deviations are documented appropriately and associated CAPA plans are successfully implemented.
- Ability to work independently and travel, as needed between the USA and Canada (Passport required)
- Adoptive cellular therapy experience highly desired, especially in solid tumor oncology indications.
- Trial management experience from to completion highly desired, especially with CRO and/or central laboratory management activities.
- Proven ability to build strong relationships and collaborate effectively with internal and external counterparts.
- Thorough knowledge of current Good Clinical Practice (GCP ICH), as well as FDA and international requirements/regulations.