Senior Clinical Trial Manager

The Senior Clinical Trial Manager plays a critical role in the strategic planning and execution of clinical trials from study start-up through close-out. This individual will oversee CROs, vendors, and clinical trial sites, while partnering cross-functionally to ensure trials are delivered on time, within budget, and in compliance with regulatory requirements, GCP guidelines, and internal SOPs. This role is a key contributor to clinical operations strategy and execution, supporting high-quality operational delivery in a fast-paced clinical development environment. Essential Functions and Responsibilities Lead end-to-end execution of clinical trials from protocol development through clinical study report (CSR) readiness, supporting complex oncology programs. Oversee CROs, vendors, and clinical trial sites to ensure operational excellence and milestone adherence. Maintain inspection readiness through accurate and complete study documentation and trial master files (TMF). Organize and lead study-related meetings, including agenda development, minute-taking, and documentation archiving. Coordinate clinical trial supplies, equipment, and cross-functional activities (e.g., data review meetings). Ensure compliance with study-specific training requirements and conduct TMF reviews for completeness and quality. Support clinical sites in audit and inspection preparation. Assist with clinical trial budgets and day-to-day operational activities in accordance with SOPs, ICH/GCP, and regulatory standards. Monitor subject enrollment, site performance, and key study metrics; perform quality checks across study components. Proactively identify, resolve, and elevate risks or issues impacting study timelines or deliverables. Contribute to study start-up activities including protocol and synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation. Collaborate with CROs to ensure timely collection, review, and archiving of essential TMF documents. Partner cross-functionally on regulatory and essential document submissions. Support study close-out activities including TMF finalization, drug reconciliation, and CSR readiness. Foster strong collaboration and communication across study teams and key stakeholders. Participate in continuous process improvement and quality initiatives. Perform additional responsibilities as needed. Required Education, Experience, Skills, and Abilities Bachelor’s degree with a minimum of 5 years of hands-on clinical trial experience in a pharmaceutical, biotech, or CRO environment. Proven experience managing oncology clinical trials, including start-up, execution, and close-out. Global clinical trial experience required; EU experience highly desirable. Strong working knowledge of ICH/GCP and regulatory requirements. Proficiency with clinical systems including eTMF, CTMS, EDC, and related platforms. Ability to work independently while thriving in a collaborative, cross-functional environment. Strong critical thinking skills with a proactive, solutions-oriented mindset. Excellent written, verbal, and interpersonal communication skills. Proficient in MS Office and comfortable adopting new technologies. Minimal travel required (approximately 0–5%). #J-18808-Ljbffr Brio Group