Ben Leahy
Clinical Trial Manager Ii @Syneos Health
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WORK HISTORY
Clinical Trial Manager Ii @Syneos Health
Houston, TX, US
Responsible for team member clinical/site management project deliverables as the clinicalfunctional team leader. Drives and manages the clinical and site management aspects ofassigned project- Reviews the study scope of work, budget and protocol content and ensures the clinical projectteam (CRAs/CMAs) are aware of the parameters- Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), CaseReport Form (CRF), drug management, safety, Trial Master File, IVRS/IWRS enrollment,Data Visualization dashboards to oversee site and study team conduct, to ensure timely entry of all operational aspects according to plan, and to oversee site and study team conduct- Ensures quality of the clinical monitoring and site management deliverables within a projectand maintain proper visibility of its progress by the use of approved systems or trackingtools, including the development of the Clinical Management Plan- Implements the monitoring strategy required for the study and where required participates inthe development of the study risk assessment plan. Is accountable for the clinical teamsunderstanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans- Reviews the content and quality of site monitoring documentation (site monitoring calls, sitevisit reports, site letters, and pertinent correspondence), to ensure they represent sitemanagement activities and conduct- Maintains compliance in assigned region or project for performance, deliverables, andassociated KPI\'s- Interacts and engages with the client and other functional departments related to clinicalmonitoring and site management activities and deliverables- Evaluate staff\'s competency to perform visits/site contact independently via sign-off visits andMonitoring Evaluation Visits- Participates in business development proposals, defense meetings and proposal development- Involved in Business Unit-level initiatives.
EDUCATION
Appalachian State University
Bachelor of Science (BS), Health Promotion
Appalachian State University
Health Promotion
SKILLS
ABOUT BEN LEAHY
Experienced Clinical Research Professional, passionate about bridging the gap between Clinical Research and IT solutions. Demonstrated history of working in Clinical Research, Clinical Team Management, and Clinical Research Software and Process Development. Skilled in Project Management, Budget and Financial Analysis, Risk Management, Metrics, Feasibility, Site Management, and Customer Service. Experience managing multiple mid to high level complexity projects on time and within budget.
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