Clinical Trial Manager 2 (CTM2) - Oncology Clinical Trials

Overview of Role:

The Clinical Trial Manager 2 (CTM2) is an experienced clinical operations professional accountable for all aspects of Clinical Trial Management for global studies. The CTM2 oversees study startup and maintenance through study closeout, coordinates, leads, and drives deliverables for assigned sites, countries, or regions for one or more studies or programs simultaneously. The CTM2s are also accountable for site, country, or region performance metrics and the quality of deliverables in the clinical trial.

Role and Responsibilities:

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Partner with the CRO to ensure robust clinical trial execution, data monitoring strategies, and patient enrollment strategies.
• Draft, review, and manage study-related plans, processes including Informed Consent Forms, Investigator agreements (CTA), CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management, and safety monitoring as delegated.
• Review and approve essential document packages.
• Track and ensure resolution of Risk-Based Quality Management actions and signals.
• Conduct sponsor oversight of CRO monitoring activities by reviewing all types of monitoring reports; monitor site performance, identify quality trends, and ensure timely resolution of monitoring findings and action items.
• Perform quality oversight visits.
• Review clinical data listings, reports, and dashboards ensuring data currency and completeness inclusive of laboratory, imaging, and other protocol-required assessments.
• Identify trends and follow up on outstanding data issues with CRO and Study team.
• Responsible for oversight on the maintenance and completeness of the TMF (Trial Master File), performing periodic quality reviews.
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices (GCP). Ensure compliance of clinical trials with national and international regulatory requirements.
• Ensure inspection readiness.
• Mentor and provide guidance to CTMs, CRAs, and other Clinical Operations team members.
• All other duties as assigned.

Experience, Education, and Specialized Knowledge and Skills:

• A Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related area is preferred.
• 6+ years of clinical trial management experience in conducting international clinical trials in sponsor Pharma/Biotech organizations.
• 5+ years of direct clinical trial management experience, including oversight of phase II/III clinical trials. Global oncology experience is preferred.
• Ability to travel internationally to visit clinical sites and study meetings. Amount will vary upon project needs (up to 20%).
• Demonstrated ability to comprehend complex scientific concepts and proficiency in reviewing and assessing clinical data.
• Possesses excellent planning, time management, and project coordination skills.
• Demonstrated ability to identify and manage operational risks and develop effective mitigation strategies.
• Ability to work independently and collaboratively to manage and prioritize work in a fast-paced environment.
• Consistently demonstrates the ability to solve problems and use sound judgment in relation to regulatory requirements, interactions with external parties, timelines, and moderately to high clinical programs.
• Strong planning, communication, and organizational skills.
• A solid understanding of the drug development process, ICH guidelines/GCP, and specifically, each step within the clinical trial process.