Manager, Clinical Trial Management - Oncology (U.S.)
Worldwide Clinical Trials
Summary
Bring your clinical research and leadership experience to a role where you will help drive the quality and timely delivery of site management services across clinical programs and projects.
Job description
You will provide therapeutic and operational expertise throughout the delivery lifecycle, lead and develop assigned clinical research staff, and help ensure projects have the resources, training, and strategies needed for effective execution.
Working closely with Project Management, Site Management, Study Start Up, therapeutic teams, and Global Quality Assurance, you will strengthen collaboration, monitor project health and quality, and develop practical solutions that support successful clinical trial delivery.
Where You'll Work
This is a remote role open to candidates based in United States. You will collaborate with global teams across multiple time zones. Ability to travel up to 30% required, including some international travel.
What You'll Do
- 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.
What You'll Bring
- 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; therapeutic knowledge is desired.
- 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, with 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.
Requirements
- Four-year college curriculum with a major concentration in biological, physical, health, pharmacy, or another related science
- 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
- Broad protocol knowledge and 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 InForm and Medidata
- Understanding of clinical data collection and editing
- Strong strategic thinking and problem-solving skills
- Excellent written, verbal, and interpersonal communication skills
- Proficiency in English
- Ability to travel up to 30%, including some international travel
Benefits
- Competitive benefits package
Company overview
Worldwide Clinical Trials is a leading global contract research organization (CRO) that provides comprehensive clinical development services to pharmaceutical, biotechnology, and medical device companies. Founded with a mission to accelerate the development of innovative therapies, the company offers end-to-end solutions spanning from early-phase research through late-stage clinical trials and regulatory submissions. With expertise across multiple therapeutic areas including oncology, central nervous system disorders, cardiovascular diseases, and rare conditions, Worldwide Clinical Trials leverages its scientific knowledge and operational excellence to design and execute complex clinical studies. The organization maintains a global footprint with operations across North America, Europe, and Asia-Pacific regions, enabling it to conduct multinational trials efficiently. Known for its patient-centric approach and commitment to quality, Worldwide Clinical Trials plays a crucial role in advancing medical research and bringing new treatments to patients worldwide.