Director CTM– Perm – Remote (EST) - $170,000 - $220,000
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.
A Pharmaceutical Company is seeking a Director CTM.
• 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
• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with company’s culture and values – courageous, imaginative, selfless and joyful
• Strong written and verbal communication skills
• Excellent problem-solving skills and a strong sense of urgency
• Strong interpersonal skills
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.
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Hays is an Equal Opportunity Employer.
Drug testing may be required; please contact a recruiter for more information. #1136855