Shannon Nesbeitt
Manager, Study Start-up and Feasibility (Including Records Management) @Evestia Clinical
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WORK HISTORY
Manager, Study Start-up and Feasibility (Including Records Management) @Evestia Clinical
US
Spearhead site feasibility and selection strategies across therapeutic areas, ensuring alignment with activation goals, enrollment targets, and study requirements.• Drive start-up timelines to meet aggressive launch targets, ensuring documentation accuracy and regulatory compliance.• Collaborate with clinical operations, regulatory, and project teams to align site selection with study objectives and timelines.• Line Manager for TMF Records Managers and Administrators.• Lead TMF operations including eTMF configuration, room setup, TMF vendor oversight, and project close-out activities.• Oversee start-up activities including regulatory submissions, contract negotiations, and site initiation visits (SIVs).• Serve as liaison between sponsors, sites, and internal teams to ensure seamless communication throughout start-up.• Proactively resolve regulatory, contractual, and site readiness issues to mitigate activation risks.• Manage start-up vendors, monitor performance, and enforce contractual obligations.• Mentor junior staff, supporting professional development and promoting best practices.• Prepare and present detailed start-up metrics, milestones, and risk assessments to senior leadership.• Manage a cross-functional team encompassing feasibility, start-up, and systems professionals.• Customize feasibility assessments per protocol; develop tailored questionnaires and site engagement strategies.• Collaborate with study teams to track risk mitigation plans, timelines, and performance metrics.• Ensure system tracking aligns with milestone deliverables and quality standards.• Partner with Medical Affairs, Regulatory, and Clinical Operations to ensure trial readiness and compliance.• Responsible for overseeing clinical development resourcing activities, including forecasting, allocation, and optimization of internal and external resources to ensure timely and efficient execution of clinical programs.
EDUCATION
University of Washington
Law Societies and Justice (BA)
SKILLS
ABOUT SHANNON NESBEITT
Strategic and results-driven Study Start Up and Feasibility Manager with over 10 years of experience in global clinical trial operations. Proven expertise in leading site feasibility, selection, and start-up activities across diverse therapeutic areas for Phase studies. Seasoned Clinical Operations and TMF Leader with a decade of progressive experience in global clinical trial management and Trial Master File (TMF) operations across oncology, rare diseases, and complex therapeutic areas. Adept in global regulatory compliance including ICH-GCP, 21 CFR Part 11, and EMA/FDA guidelines. Strong collaborator and mentor, with a track record of improving processes, mitigating risks, and ensuring compliance with global regulatory standards. Adept at managing cross-functional teams, vendor relationships, and site performance to deliver on-time and high-quality study initiations.
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