Sr. Clinical Trial Manager

The Senior Clinical Trial Manager will oversee the execution of clinical studies across multiple geographic regions, ensuring compliance with Good Clinical Practices, Standard Operating Procedures, FDA regulations, and ICH guidelines. This role involves interaction with both internal and external stakeholders and requires strong communication, decision-making, and clinical project management skills. The position reports to an Associate Director responsible for Operational Study Strategy and may involve both strategic and execution responsibilities.

Responsibilities

• Lead the development of clinical study plans, including critical path activities and interdependencies.
• Create and manage the Clinical Study Oversight Plan, ensuring adherence by study teams and vendors.
• Provide operational input into study protocol profiles and amendments.
• Coordinate document reviews and medical writing tasks, such as ICF, CRF guidelines, and safety communications.
• Manage CRO and vendor selection processes in collaboration with study teams.
• Oversee trial feasibility, site identification, and qualification activities.
• Monitor clinical trial performance and quality metrics, addressing issues and risks as needed.
• Ensure adherence to internal procedures for study planning, conduct, and reporting.
• Monitor study budget and ensure alignment with financial expectations.
• Oversee CRO and third-party vendor management, ensuring compliance with quality measures and timelines.
• Coordinate operational activities, including interim analysis and study close-out tasks.
• Support departmental knowledge sharing and training initiatives.

Must Have Experience

• Expertise in oncology and clinical operations.
• Proficiency in CRO management and patient enrollment.
• 7+ years of experience in the pharmaceutical or biotech industry.
• Experience with clinical study start-up, site management, and global clinical study management.
• Experience in vendor management and recruitment strategies.

Additional Qualifications

• Bachelor's degree in Science or related field.