Remote Oncology Clinical Trial Management Lead

Worldwide Clinical Trials; United States; Remote; USD 112,000 - 222,000; Full time

Job summary

Worldwide Clinical Trials seeks a Manager, Clinical Trial Management - Oncology to drive quality and on-time delivery of site management services across programs and projects.

You will lead and develop Clinical Research Associates and Lead CRAs, partner with Project Management and Study Start Up, and ensure resourcing, training, and strategies support successful oncology trials. Remote role across the United States with up to 30% travel.

Qualifications

• Four-year college degree in a related science and eight years of clinical research experience as a CRA, or equivalent education with ten years CRA experience.
• Experience managing Clinical Trial Managers and leading staff.
• Broad protocol knowledge and understanding of the biopharma industry, drug development lifecycle, and operational clinical trial delivery.
• Strong knowledge of FDA regulations, ICH Guidelines, HIPAA and SOPs.
• Experience with EDC systems (InForm, Medidata) and data collection/editing.

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, helping ensure 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 through key 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.

Skills

Leadership & staff management

Therapeutic/clinical trial delivery

Strategic thinking & problem-solving

Communication skills (English)

FDA/ICH/HIPAA knowledge

EDC systems (InForm, Medidata)

Education

Bachelor's degree in biological/physical/health/pharmacy or related science + 8 years CRA experience; or equivalent

Job description

Worldwide Clinical Trials seeks a Manager, Clinical Trial Management - Oncology to drive quality and on-time delivery of site management services across programs and projects.

You will lead and develop Clinical Research Associates and Lead CRAs, partner with Project Management and Study Start Up, and ensure resourcing, training, and strategies support successful oncology trials. Remote role across the United States with up to 30% travel.