Manager, Clinical Trial Management - Oncology (U.S.)
About The Position
The Manager, Clinical Trial Management - Oncology leads the quality and timely delivery of site management services across clinical programs and projects. The role provides therapeutic and operational expertise throughout the program and project delivery lifecycle, ensuring effective delivery strategies, appropriate resourcing, and project support. Working with Project Management, Site Management, Study Start Up, therapeutic teams, and Global Quality Assurance, the Manager coordinates clinical delivery, monitors project health and quality, and identifies practical improvements. The role develops and manages Clinical Research Associates (CRAs) and Lead Clinical Research Associates (Lead CRAs), including project-specific training, quality of clinical work, and appraisal performance reviews. The position is remote for candidates based in the United States and requires travel of up to 30%, including some international travel.
Requirements
- A four-year college curriculum with a major concentration in biological, physical, health, pharmacy, or another related science, plus eight years of clinical research experience as a Clinical Research Associate; or equivalent education/training plus ten years of Clinical Research Associate experience.
- At least two additional years of experience managing Clinical Trial Managers, with the ability to lead staff and support effective clinical delivery.
- Broad protocol knowledge and a comprehensive understanding of the biopharma industry, drug development lifecycle, and operational clinical trial delivery.
- Strong knowledge of FDA regulations, ICH Guidelines, HIPAA, clinical research principles, and standard operating procedures.
- Experience navigating EDC systems, including platforms such as InForm and Medidata, along with an understanding of clinical data collection and editing.
- Strong strategic thinking and problem-solving skills, including the ability to make decisions, plan effectively, stay organized, and maintain attention to detail.
- Excellent written, verbal, and interpersonal communication skills, including proficiency in English.
- Ability to travel up to 30%, including some international travel.
Nice To Haves
- Therapeutic knowledge.
Responsibilities
- Lead the quality and timely delivery of site management services provided by assigned Clinical Research Associates across therapeutic programs and projects.
- Provide therapeutic and operational expertise throughout the program and project delivery lifecycle, supporting appropriate resourcing and effective delivery strategies.
- Partner with Project Management, Site Management, Study Start Up, therapeutic teams, and Global Quality Assurance to coordinate clinical delivery and address project needs.
- Develop Clinical Research Associates and Lead Clinical Research Associates through project-specific training, including SOPs, quality improvement and CAPA requirements, and Clinical Monitoring Plans.
- Monitor clinical quality and project health using metrics such as site visit report compliance, source data verification, onsite activity, data query status, scope of work, and resource status.
- Serve as a key contact for the Project Management Franchise Lead and support proposal defense and client meetings for new and ongoing business as needed.
- Identify opportunities to strengthen performance and quality, including training needs arising from CAPA information.
- Manage assigned staff, including the quality of their clinical work and appraisal performance reviews.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
