Sr. Clinical Trial Manager

Job description

The Senior Clinical Trial Manager will be responsible for managing operational aspects of assigned clinical trials, with a focus on early-phase oncology studies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing early phase oncology trials at a sponsor biotech. ### ESSENTIAL FUNCTIONS AND RESPONSIBILITIES - Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations. - Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards. - Manage, mentor, and support direct reports, fostering professional development and team performance. - Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with investigators and site staff to support efficient enrollment and high-quality data collection. - Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals. - Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented. - Conduct ongoing data reviews and support data cleaning activities. Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF). - Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders. - Work closely with internal stakeholders including Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs. - Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement. - Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings. - Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance. - Willingness to travel up to 15% for site visits, vendor meetings, and conferences. - Other activities as assigned.