Manager, Clinical Trial Management - Oncology (U.S.)

Worldwide

North Carolina

Remote

USD 112,000 - 222,000

Full time

2 days ago
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Benefits offered by this job

Remote work option
Travel up to 30%

Job summary

Worldwide Clinical Trials in the United States is seeking a Manager, Clinical Trial Management - Oncology to lead site management across oncology programs, ensuring timely, high-quality trial delivery. You will mentor Clinical Research Associates and Lead CRAs, coordinate with PM, Site Management, and QA, and drive resourcing and CAPA initiatives.

This remote role, open to US-based candidates, requires extensive CRA leadership experience, knowledge of FDA/ICH guidelines, and proficiency with EDC

Qualifications

  • Four-year college degree in a biological/physical/health/science field required.
  • Eight years of clinical research experience as a CRA; or equivalent education/training with ten years of CRA experience.
  • Two additional years of experience managing Clinical Trial Managers.
  • Strong knowledge of FDA regulations, ICH Guidelines, HIPAA, and SOPs.
  • Experience navigating EDC systems like InForm and Medidata.

Responsibilities

  • Lead the quality and timely delivery of site management services across programs.
  • Provide therapeutic and operational expertise throughout the delivery lifecycle.
  • Develop and mentor CRAs and Lead CRAs through project-specific training.
  • Coordinate with Project Management, Site Management, Study Start Up and QA.

Skills

Clinical Trial Leadership
Staff Development
Regulatory Knowledge
English Proficiency
Strategic Thinking

Education

Bachelor's degree in Biological/Physical/Health/Pharmacy or related science

Tools

InForm
Medidata

Job description

Manager, Clinical Trial Management - Oncology (U.S.)We use cookies to improve your browsing experience and help us improve our websites. We have carefully selected third parties that use cookies to achieve purposes illustrated in the cookie policy. For more information. Read more about online privacy statement. By closing this banner or continuing to browse our website, you agree to our use of such cookies.https://www.worldwide.com/privacy-statement-terms-of-use/online-privacy-statement/# Discover a world of difference at Worldwide.## Manager, Clinical Trial Management - Oncology (U.S.)Apply: Remote: Research Triangle Park, North Carolina: Full time: Posted Today: JR103409Join a global Contract Resource Organization (CRO) where innovation meets purpose. At **Worldwide Clinical Trials**, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. **Make an Impact as a Manager, Clinical Trial Management - Oncology at Worldwide** 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. 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. **Discover the Difference** We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit **http://www.worldwide.com/careers**, or connect with us on **LinkedIn**. At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $112,000.00 - $222,000.00The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law**.**
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