Job Title

Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. * Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. * Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams. * For studies where data management activities are conducted within Takeda, leads and manages clinical trial data collection set-up, data review, and database lock: (a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. (b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans. (c) Leads data review, including query management, and leads activities required for interim and final database locks. (d) May oversee above activities at the program level. * Participates in preparing function for submission readiness. * Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. * Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. * Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. * Acts as a process expert for operational and oversight models. * May prepare metrics to support the function’s KPIs. * Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.