Senior Clinical Trial Manager

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

📋 Description

• Provide strategic leadership and operational oversight for intricate global clinical trials.

• Guide study deliverables across designated sites, countries, or regions from protocol development assistance to closeout and inspection readiness.

• Manage site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout processes.

• Act as the primary operational lead and escalation contact for CROs.

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

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

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

• Spearhead risk-based quality management initiatives and address signals, actions, risks, and trends.

• Supervise CRO monitoring activities and evaluate monitoring trip reports.

• Conduct quality oversight visits concentrated on inspection readiness.

• Lead the review of clinical data listings, reports, and dashboards; identify trends and risks, and facilitate cross-functional resolutions.

• Oversee the maintenance, quality, completeness, and reviews of the Trial Master File.

• Ensure compliance of clinical trial activities with Good Clinical Practices and both national and international regulatory requirements.

• Direct audit and regulatory inspection preparations while supporting inspection management.

• Manage, mentor, and guide CTMs, CRAs, and other Clinical Operations staff.

• Propel continuous improvement and contribute to Clinical Operations processes and standards.

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

• Perform additional duties as assigned.

⛳️ Requirements

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

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

• 7+ years of hands-on clinical trial management experience overseeing phase II/III international oncology clinical trials.

• Willingness to travel internationally to visit clinical sites and attend study meetings, up to 20% based on project needs.

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

• Proficiency in managing large, intricate studies conducted in-house and by a CRO.

• Strong problem-solving skills concerning regulatory requirements, external parties, timelines, and complex clinical programs.

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

• Excellent planning, leadership, communication, negotiation, and organizational abilities.

• Expert understanding of the drug development process, ICH guidelines, and GCP.

• Profound knowledge of all phases of clinical trial execution and the capability to apply this expertise to complex global studies.

🏝️ Benefits

• Bonus

• Stock

• Benefits

• Potential variable compensation

• International travel opportunities (up to 20%)