The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
An American Company is seeking a Remote Senior Clinical Trial Manager
• Responsible for the successful execution of one or more clinical studies from study planning to close-out
• Leads cross-functional Study Management Team meetings; facilitates discussions and decision-making across functions
• Manages study finances. Negotiates vendor contracts, ensuring clarity in contracts and budgets, and oversees vendor performance to contract and agreed budget.
• Participates in development of study timelines, ensuring close coordination between the company study team and external parties. Manages trial according to agreed timelines
• Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs
• Communicates risks to timelines, budgets, or quality and participates in establishing and overseeing mitigation strategies
• Leads site and vendor selection activities and oversees Trial Master File management
• Oversees the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and ensures trial activities are conducted in accordance with agreed plans
• Maintains strong relationships with CROs, vendors, and investigative sites
• Works in partnership with key internal functions including, but not limited to Finance, Legal, Regulatory, Biometrics, Clinical Development, and Medical Affairs
• Participates in SOP / process development and other department initiatives, as needed
Skills & Requirements
• Bachelor’s degree in scientific discipline required; master’s degree or higher preferred
• At least 8 years’ experience in clinical operations in biotech / pharma companies and/or CRO
• Experience managing Phase 1-3 multinational clinical trials, including successful management of cross-functional teams
• Experience with vendor and site selection, contracts and budgeting, and vendor and site oversight
• Demonstrated expertise in Good Clinical Practice; experience with sponsor regulatory inspection(s) preferred
• Working knowledge of data management, regulatory operations, and pharmacovigilance
• Willingness to be an individual contributor or hands-on team leader, according to project demands
• Experience managing neuroscience, oncology, or rare disease clinical trials strongly preferred
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.
Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1140265