Role OverviewWe are seeking an experienced Clinical Trial Manager to provide both strategic leadership and hands-on oversight of early-stage oncology trials, including first-in-human trials. The role involves overseeing all aspects of trial management, ensuring trials are delivered on time, on budget, and fully compliant with regulatory and quality standards.
What You Will Do
Work with a cross-functional trial team to manage all aspects of clinical trials, manage outsourced activities with CROs and vendors, manage trial budgets and contracts, monitor trial progress, and ensure Trial Master File (TMF) completeness.
Why It Might Be a Fit
This is a hands-on role in a fast-paced, collaborative environment, offering the opportunity to directly influence the advancement of innovative therapies for patients. The ideal candidate will have a proven track record in CRO and vendor management, experience in data management, biostatistics, and pharmacovigilance, and a thorough understanding of FDA regulations and ICH GCP guidelines.
Requirements
- Bachelor’s degree in Life Sciences or related field (advanced degree preferred)
- 3+ years of clinical trial management experience
- Proven track record in CRO and vendor management
- Working knowledge of data management, biostatistics, and pharmacovigilance
- Global trial experience, including management of multi-country trials from start-up through close-out
- Thorough understanding of FDA regulations and ICH GCP guidelines
- Proficiency with clinical trial systems (EDC, CTMS, TMF)
- On-site monitoring experience (preferred)
- Excellent communication skills, with the ability to collaborate effectively across teams
- Highly organized with strong problem-solving, critical thinking, and prioritization skills
- Ability to travel domestically and internationally, up to 20%
Benefits
- Medical, dental, vision, and life insurance
- Flexible time off
- 401(k) retirement plan
- Short- and long-term incentive opportunities
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