Clinical Trial Manager

The Clinical Trial Manager (CTM) plays a key role in the successful execution of clinical research studies, providing operational leadership from study initiation through final closeout. This position is well-suited for a highly organized professional who excels in a collaborative environment, proactively addresses challenges, and thrives in a growing, fast-paced biotechnology setting. The CTM will manage relationships with CROs and vendors, oversee study timelines and budgets, and ensure that clinical trials are conducted efficiently, compliantly, and with a high standard of quality.

• Contribute to study planning activities, including protocol implementation, startup efforts, site feasibility, selection, and activation in partnership with Clinical Operations leadership.
• Support the creation, review, and maintenance of essential study documentation, including protocols, informed consent forms, study manuals, and training materials.
• Ensure clinical studies comply with applicable regulations, ICH-GCP standards, and internal procedures throughout the study lifecycle.

• Act as the primary operational liaison for contract research organizations (CROs) and external service providers.
• Monitor study progress, including site performance, patient enrollment, monitoring activities, and risk mitigation efforts.
• Evaluate vendor deliverables, performance indicators, and quality metrics, identifying and escalating concerns when necessary.

• Assist with management of study budgets, timelines, forecasting activities, and support the development of contracts and statements of work.
• Facilitate cross-functional study team meetings and promote effective communication among Clinical Development, Biostatistics, Data Management, Safety, Regulatory Affairs, and other stakeholders.
• Support inspection readiness initiatives and participate in audit responses, corrective actions, and process improvements.

• Collaborate with Data Management teams to support database development, data review, query resolution, and data cleaning activities.
• Review clinical data outputs, protocol deviations, and safety-related documentation to ensure quality and compliance.
• Maintain complete, accurate, and inspection-ready Trial Master File (TMF) documentation.

• Coordinate site closure activities, reconciliation processes, and final study deliverables.
• Contribute to Clinical Study Report (CSR) development and capture lessons learned to support continuous improvement initiatives.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline; advanced degree preferred.
• Minimum of 5 years of clinical operations experience within the biotechnology, pharmaceutical, or clinical research industry, including direct management of clinical studies.
• Strong knowledge of clinical trial operations, ICH-GCP guidelines, regulatory requirements, and vendor oversight practices.
• Prior experience working in startup, small biotechnology, or growth-stage organizations is highly desirable.
• Demonstrated ability to manage multiple projects simultaneously, identify risks early, and work independently while collaborating effectively with senior leadership.
• Excellent project management, communication, organizational, and cross-functional leadership skills.
• Proven ability to build productive partnerships with internal teams, investigators, CROs, and external vendors.