Senior Global Trial Manager – Single SponsorAre you experienced in managing late phase clinical trials at a global level? Join our Single Sponsor Department and take ownership of delivering late‑phase clinical trials that meet timelines, budgets, and quality standards. As a core Clinical Trial Team member, you'll lead critical aspects of global studies and collaborate across functions to drive success.As part of your role, you’ll have the opportunity to specialize in one of the following areas:Scientific Review Committee (SRC)Non‑Interventional Studies (NIS)Managed Access Programs (MAP)Investigator‑Initiated Trials (IITs)Research Collaborations (RCs)Program Level Documents (PLD)Key ResponsibilitiesClinical Documentation & Study ToolsDraft sections of protocols, CRFs, training materials, and data review plansContribute to the development of safety updates, IBs, and regulatory submissionsProject LeadershipOversee data review and TMF audit readinessForecast/manage investigational product supplySupport study closeout, issue resolution, and lifecycle budget trackingContribute to Managed Access Program coordination and complianceVendor & Stakeholder ManagementCoordinate CRO/vendor selection and performanceFacilitate advisory boards (DMCs/Steering Committees) and serve as the site liaisonLead cross‑functional collaboration with data management, drug supply, and moreWhat You’ll BringAdvanced degree in life sciences or healthcare2–5 years' global experience managing phase IV, PASS, PAES, or NIS trialsStrong track record in protocol development, study startup, and regulatory writing (e.g. PSURs, DSURs, NDA/BLA reports)Excellent communication, organizational, and collaboration skillsDeep understanding of GCP and clinical trial designPassion for advancing real‑world evidence and patient outcomesPlease note this role is not eligible for the UK visa sponsorship.Please note: due to sponsor requirements for the role only candidates based in the listed location(s) will be considered. Any applications from candidates based outside of these locations will not be considered.
#J-18808-Ljbffr