Ryan Thys

Experience

1. Senior Clinical Project Manager

   Replimune

   Apr 2023 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase I-IVProvide leadership and a strategic direction within the department and expert guidance in the operational aspects of executing clinical development deliverablesDrive study execution, including management and oversight of CROs, vendors and consultants involved with the clinical trial and program.Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.Leads risk identification, management, and mitigation efforts and reporting progress to senior leadership Provides strategic input and leads investigator recruitment/selection across project/program.Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs.Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs.Drive preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.Maintain primary responsibility for the content of and execution on all study-related operational plansResponsible for evaluation and reporting on aggregate site metric/KPI dataActive participation with the development of the clinical components of regulatory submissionsActive participation in forecasting Investigational Medicinal Product and clinical trial suppliesEnsure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trialParticipate and respond to Quality Assurance audits and/or regulatory authority inspections. Responsible for ongoing study communication and escalation of study-related issues as required.