Shannon Hayes

Clinical Operations Lead @Everest Clinical Research

Provide leadership, local/global strategic planning, and operational delivery of assigned clinical studies/program through all phases of study management (study start-up, conduct/maintenance, closure), in accordance with Everest quality standards, all applicable regulations, timelines, and budget commitments. • Ensure the effective identification, initiation, and motivation (patient recruitment/retention) of clinical study sites. • Focus on internal and external customers service (Sponsors, study sites, vendors) related to site management and clinical monitoring activities to ensure timely and high quality deliverables through Clinical Trial Management System (CTMS)/electronic Trial Master File (TMF) and/or tracking tools. • Provide oversight and quality control review for set-up and maintenance of studies in CTMS and TMF. • Drive the successful activation of trial sites according to time, quality/scope, and budget parameters. • Serve as initial point of contact for all clinical management and monitoring issues, vendors, and other functional areas, escalating as required. • Develop a monitoring plan and monitoring tools. • Oversee the preparation, conduct, and timely completion of all monitoring visit reports, review them for appropriate content, and ensure effective follow up and resolution of site issues. May conduct monitoring visits as necessary. • Collaborate with other functional departments to identify issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk. • Assist functional clinical operations delivery team. • Assist with the preparation and negotiation of sites contracts/budgets and prepare payments for vendors/study sites. • Assist with preparation and submission of regulatory documents to responsible regulatory agencies, authorities, Institutional Review Boards and/or Research Ethics Committees. • Monitor the quality of clinical deliverables and address quality issues with the appropriate team member.