Clinical Trial Manager II

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Supervise site selection, feasibility assessments, activation, enrollment, monitoring, escalation of issues, and closeout activities.

• Collaborate with the CRO to guarantee effective execution of clinical trials, data monitoring approaches, and strategies for patient enrollment.

• Prepare, review, and manage study-related plans and procedures, including informed consent forms, investigator agreements, CRFs, CRF guidelines, statistical and pharmacokinetic analysis plans, monitoring plans, data management, and safety monitoring as assigned.

• Evaluate and approve essential document packages.

• Monitor and ensure resolution of Risk-Based Quality Management actions and signals.

• Conduct sponsor oversight of CRO monitoring activities by reviewing monitoring reports, assessing site performance, identifying quality trends, and addressing findings and action items.

• Carry out quality oversight visits.

• Review clinical data listings, reports, and dashboards for accuracy and completeness.

• Identify trends and follow up on unresolved data issues with the CRO and study team.

• Ensure the proper maintenance and completeness of the TMF and conduct periodic quality reviews.

• Oversee clinical trial operations in line with Good Clinical Practices and ensure adherence to regulatory standards.

• Maintain inspection readiness.

• Mentor and support CTMs, CRAs, and other members of the Clinical Operations team.

• Perform additional assigned tasks.

⛳️ Requirements

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

• A minimum of 6 years of clinical trial management experience, specifically in conducting international clinical trials within sponsor Pharma/Biotech organizations.

• At least 5 years of direct clinical trial management experience, including oversight of Phase II/III clinical trials.

• Willingness to travel internationally to clinical sites and study meetings, up to 20% of the time.

• Capacity to understand complex scientific concepts and evaluate clinical data.

• Proficient in planning, time management, and project coordination.

• Ability to identify and manage operational risks while developing effective mitigation strategies.

• Capable of working independently and as part of a team in a fast-paced environment.

• Skilled in problem-solving and exercising sound judgment concerning regulatory requirements, external parties, timelines, and moderately to highly complex clinical programs.

• Strong planning, communication, and organizational abilities.

• Familiarity with the drug development process, ICH guidelines/GCP, and each phase of the clinical trial process.

🏝️ Benefits

• Bonus, stock options, benefits, and/or other applicable variable compensation may be part of the overall compensation package.

• Opportunities for international travel, up to 20%, depending on project requirements.