Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs.
Maintain and configure safety databases (e.g., ArisG, Argus, or similar) to support case processing, reporting, and compliance.
Ensure accuracy, completeness (experience with UAT testing), and regulatory compliance of safety data in accordance with global PV regulations (FDA, EMA, ICH, etc.).
