Specialist Study Start Up & Regulatory Affairs

The Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan. They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate and industry regulatory strategies. Under guidance of senior team members, independently manages study start-up activities for projects of low complexity, ensuring effective coordination and delivery of assigned. Prepare, collect, review regulatory information to support submissions to national authorities and ECs/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations. Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval. Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines. Responsible for site outreach in assigned country/countries; point of contact for site, sharing of non-confidential and confidential study information and management of confidential disclosure agreements Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to site activation readiness investigational product release, site activation and site initiation. Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance