Clinical Trial Manager, FSP

Life Technologies

Full-time

Miscellaneous Manufacturing

About the position

The Clinical Trial Manager (CTM) is responsible for overseeing the operational deliverables of clinical studies from the Final Protocol Concept Sheet to the Clinical Study Report (CSR). This role involves cross-functional management and operational expertise to ensure that clinical trials are executed within quality standards, timelines, and budgets, while adhering to regulatory requirements. The CTM may lead a cross-functional Clinical Trial Team (CTT) for less complex trials and is accountable for managing global clinical trial operations, including planning, coordination, and implementation of assigned studies.

Responsibilities

• Establish and lead the cross-functional CTT in partnership with the Lead Trial Physician, if applicable.
• Work with functional leaders to assign CTT representatives from involved functional areas.
• Ensure clinical trials are executed according to protocol requirements, trial plans, OGSM, client procedures, ICH-GCP, and other applicable regulations.
• Communicate transparently and collaborate with CTT members & external partners to achieve clinical trial objectives.
• Oversee cross-functional planning, track study progress, and proactively manage completion of trial deliverables and milestones.
• Lead, guide, and oversee CROs and other vendors to ensure contractual obligations are met according to plan and metrics.
• Manage CTT risk identification & mitigations, suggest and collaborate on solutions, manage contingency planning, and oversee implementation.
• Implement corrective and preventative actions as needed.
• Maintain awareness of risks or issues that could have cross-indication, cross-franchise, or cross-asset impact and escalate as needed.
• Contribute to the evaluation, selection, and contracting of CROs and vendors.
• Ensure scope of work aligns with protocol requirements and established budget and timelines.
• Oversee contract management and ensure services are delivered per contract.
• Ensure accurate trial budget management, timely management of scope changes, and budget reconciliations.
• Ensure CTT members receive appropriate trial-specific training for their function.
• Oversee setup, coordination, and conduct of Investigator Meetings.
• Develop and/or contribute to trial-related materials such as clinical protocols, study training materials, and patient information.
• Ensure vendor systems and processes are configured according to protocol requirements and implemented within established timelines.
• Contribute to the development and approval of project specifications, user acceptance testing, implementation, and change management.
• Oversee the country and site feasibility process, ensuring cross-functional alignment on regional footprint.
• Ensure timely availability of investigational product on site and maintain clinical site accountability records.
• Perform site oversight visits according to plan and review monitoring visit reports.
• Monitor data quality, completeness, and timeliness, proactively identifying and managing resolution of issues.
• Partner with client Site & Patient Engagement, CRO, and other vendors on recruitment & retention tactics.
• Ensure supportive relationships with clinical sites & trial personnel and track patient recruitment.
• Ensure timely collection, documentation, and reporting of adverse events and collaborate in submission of reports to regulatory authorities.
• Maintain and ensure the Trial Master File (TMF) is up to date and in a constant state of inspection readiness.
• Provide feedback on the performance of cross-functional CTT members and assist with onboarding new CTMs.

Requirements

• Bachelor's degree or University degree in medical or para-medical fields (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent experience.
• Minimum of 4 years experience in global Clinical Trial Management roles.
• Experience managing global clinical trial operations, CRO oversight, feasibility, start-up, execution, and study closure.
• Knowledge of ICH-GCP and other applicable regulations to successfully execute clinical trials.
• Experience with tools and systems for managing clinical studies (MS Project, CTMS, TMF, IWRS, eCOA, eCRF databases, etc).

Nice-to-haves

• Biotech experience is a plus.
• Rare disease, Auto-immune, and/or oncology clinical trial background is a plus.