Senior Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver strategic leadership and operational management for intricate global clinical trials.

• Direct study outcomes at designated sites, countries, or regions, from protocol development assistance through to study completion and inspection readiness.

• Supervise site selection, feasibility assessments, activation, enrollment, monitoring, issue escalation, and closeout tasks.

• Act as the main operational leader and point of escalation for CROs.

• Formulate and execute strategies for patient enrollment, retention, and data quality.

• Create, review, and approve study plans, processes, and documents, including informed consent forms, investigator agreements, CRFs, analysis plans, monitoring plans, data management plans, and safety monitoring activities.

• Review and endorse essential document packages and critical study deliverables.

• Lead Risk-Based Quality Management initiatives and address signals and actions.

• Analyze CRO monitoring trip reports, assess monitoring quality, identify cross-site trends and risks, and address findings and action items.

• Conduct quality oversight visits with a focus on inspection readiness.

• Guide and review clinical data listings, reports, and dashboards; identify data trends and risks while facilitating cross-functional resolutions.

• Manage the maintenance, quality, and completeness of the Trial Master File and lead TMF quality assessments.

• Ensure that clinical trial activities adhere to Good Clinical Practices and both national and international regulatory standards.

• Prepare for audits and regulatory inspections and support inspection management.

• Oversee, mentor, and guide CTMs, CRAs, and other members of the Clinical Operations team.

• Propel continuous improvement initiatives and enhance Clinical Operations processes and standards.

• Represent Clinical Operations in cross-functional study teams and governance meetings.

• Carry out all other assigned duties.

⛳️ Requirements

• A Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical-related fields is preferred.

• 8–10+ years of experience in clinical operations within sponsor pharmaceutical or biotechnology companies.

• 7+ years of direct management experience in overseeing phase II/III international oncology clinical trials.

• Willingness to travel internationally for site visits and study meetings, up to 20% as project needs dictate.

• Demonstrated ability to interpret complex scientific concepts and critically evaluate clinical data.

• Proven expertise in managing large, complex studies both in-house and through a CRO.

• Strong problem-solving skills regarding regulatory requirements, external stakeholders, timelines, and intricate clinical programs.

• Ability to lead teams and thrive in a dynamic team environment.

• Exceptional planning, leadership, communication, negotiation, and organizational skills.

• In-depth knowledge of the drug development process, ICH guidelines/GCP, and all phases of clinical trial execution.

• Capability to apply clinical trial knowledge to complex, global studies.

🏝️ Benefits

• Bonus

• Stock

• Benefits and/or other applicable variable compensation