Senior Clinical Trial Manager

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

📋 Description

• Provide strategic direction and operational management for intricate global clinical trials

• Lead deliverables across designated sites, countries, or regions

• Assist in protocol development from study initiation to closeout and ensure inspection readiness

• Oversee site selection, feasibility assessment, activation, enrollment, monitoring, issue escalation, and study closeout

• Act as the primary operational lead and escalation point for Contract Research Organizations (CROs)

• Develop and implement strategies for patient enrollment, retention, and data quality

• Draft, review, and approve study plans, processes, and related documents

• Review and approve essential document packages and key study deliverables

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

• Supervise CRO monitoring activities, evaluate monitoring reports, and manage cross-site trends and risks

• Conduct quality oversight visits with a focus on inspection readiness

• Review clinical data listings, reports, and dashboards; identify trends and risks

• Ensure the quality and completeness of the Trial Master File and conduct TMF quality reviews

• Ensure compliance of clinical trial activities with Good Clinical Practices and regulatory standards

• Lead preparation for audits and regulatory inspections, providing support in inspection management

• Manage, mentor, and guide Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs), and other Clinical Operations personnel

• Drive initiatives for continuous improvement and develop Clinical Operations processes and standards

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

⛳️ Requirements

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

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

• 7+ years of direct experience in managing clinical trials, specifically overseeing phase II/III international oncology clinical trials

• Willingness to travel internationally for clinical site visits and study meetings, up to 20%

• Proficient in reviewing, analyzing, and critically evaluating clinical data

• Skilled in managing large, complex studies both in-house and through a CRO

• Ability to resolve issues related to regulatory requirements, external parties, timelines, and intricate clinical programs

• Capacity to lead teams and thrive in a fast-paced team environment

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

• In-depth knowledge of the drug development process and ICH guidelines/GCP

• Comprehensive understanding of all phases of clinical trial execution and the ability to apply this knowledge to complex, global studies

🏝️ Benefits

• Potential bonus

• Stock options

• Benefits and/or other applicable variable compensation

• Opportunities for international travel, up to 20% as required by project needs