Clinical Trial Manager, Senior

This is a fully remote position, open to applicants in North America.

📋 Description

• Assist the Director in managing global clinical trial execution, which includes site activation, enrollment, monitoring, and closeout activities.

• Aid the Director in facilitating cross-functional trial team meetings to ensure alignment on critical deliverables, timelines, and strategies for risk mitigation.

• Oversee the daily operational tasks for assigned studies, guaranteeing compliance with timelines, budgets, and quality standards.

• Implement vendor integration strategies to ensure seamless collaboration between CROs, central laboratories, and specialty service providers.

• Serve as the primary clinical operations contact for assigned study-related tasks, including managing CROs and vendors in conjunction with the Director.

• Ensure the trial master file (TMF/eTMF) is complete and ready for inspection.

• Assist in the creation and upkeep of essential operational documents, such as study manuals, informed consent forms (ICFs), tracking tools, and monitoring plans.

• Take part in audits and support regulatory inspections related to Good Clinical Practice (GCP).

• Monitor compliance with regulatory and GCP standards throughout trial activities and assist in audit and inspection preparedness.

• Analyze clinical trial data listings to help identify and resolve protocol deviations, data trends, and outstanding queries.

• Oversee CRO and vendor management by tracking deliverables, proactively identifying risks until issues are resolved, and managing performance metrics in collaboration with the Program/Study Lead.

• Supervise laboratory sample management processes, including tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens.

• Contribute to the ongoing improvement of processes and the development of standard operating procedures (SOPs).

• Participate in team meetings, offering insights and updates on clinical operations to internal stakeholders.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related discipline.

• A minimum of 4 years of experience in Clinical Operations, specifically with CROs and other vendors.

• Strong comprehension of CRO/vendor management and the clinical development process.

• Experience in early-phase oncology is preferred.

• Previous experience in a lean or startup environment is highly desirable.

• Exceptional project management, communication, and problem-solving abilities.

• Familiarity with ICH-GCP and global regulatory standards.

• Proficient in clinical trial systems (such as EDC, CTMS, eTMF) and the Microsoft Office Suite.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career growth.

• Flexible work arrangements.