This role is office-based in Banja Luka, Bosnia and Herzegovina Communication and Site Management Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team, and with other PSI departments Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies Ensures proper administration of sites and vendors payments, as applicable Ensures regulatory and ethics committee submissions and notifications Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections Supports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s Meetings Maintains study-specific and corporate tracking systems Document Management Maintains Trial Master File (TMF) Performs TMF review and oversight at country and site level Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists Revises and checks translation status Safety Management Ensures proper safety information flow with investigative sites
