Sr. 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. Key Responsibilities Clinical Trial Planning & Management 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 Clinical Operations Leadership 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 Data Management & Quality Oversight 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 Study Closeout Activities 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 Qualifications 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 #J-18808-Ljbffr Clinovo