James Benedetto
@jamesbenedetto
Senior clinical operations leader driving compliant, efficient clinical trial delivery.
United StatesWhat I'm looking for
I am a strategic clinical operations leader with 13+ years managing clinical trial execution across Phases I–III, regulatory compliance, and cross-functional teams. I have led study management functions, built teams, negotiated contracts, and implemented tools and SOPs to enable decentralized and sponsor-partnered trials.
My work has delivered measurable results including leading pilots that produced 20 projects ($58M) with a $200M pipeline, securing site selections for Janssen, Moderna, and AbbVie, and developing a site-selection analytics tool and 19+ SOPs to improve feasibility and operational efficiency. I prioritize regulatory adherence, risk mitigation, and team development to advance clinical research and patient outcomes.
Experience
Work history, roles, and key accomplishments
Lead Clinical Trial Services team providing management support to Principal Investigators and ensured trials met regulatory and organizational standards across complex study designs.
Senior Manager, Operational Feasibility
CVS Health Clinical Trial Services
Jan 2022 - Jan 2023 (1 year)
Led feasibility assessments for new clinical trial opportunities, managing vendor qualification, due diligence, and developing strategic study delivery and recruitment plans.
Senior Manager, Study Management
CVS Health Clinical Trial Services
Jan 2020 - Jan 2022 (2 years)
Established and led the study management function for a clinical trial business unit, managing a team of 11 and overseeing site selection, execution, and regulatory compliance.
Senior Manager, Project Management
Coram Clinical Trials
Jan 2017 - Jan 2020 (3 years)
Directed project management team overseeing study operations, sponsor engagement, contract negotiations, and ensured protocol adherence and data integrity.
Education
Degrees, certifications, and relevant coursework
USUniversity of Colorado Colorado Springs
Bachelor of Science, Biology
Completed a Bachelor of Science in Biology providing foundational knowledge in biological sciences relevant to clinical research.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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