Vice President, Global Clinical Data Management & Technology
Global Development Support
Clinical Data Management & Technology
Responsible for ensuring timeliness and high quality for all Data Management (DM) deliverables globally within a key therapeutic area. Provides oversight of DM budget in collaboration with program management.
Provides data management expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.
Responsible for oversight of data management strategic vendor partnerships in order to maximize effectiveness and efficiency of external (CRO) resources.
Benchmarks industry best practices and changes in Data Management process, outsourcing strategies and DM vendor management.
Responsible for all vendor oversight activities across all global development programs within a key
therapeutic area for Takeda. 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.
Sets strategy and leads functional governance with Takeda’s strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and Statistics:
Design and implementation of data capture tools
Data processing, coding and validation
Responsible for the quality of the data in each database, as well as quality of other data management deliverables
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
Responsible for forecasting future outsourcing needs, assessing vendor capacity against assigned work and aligning vendor strategy with these factors.
Oversees the planning and management of external Data Management budgets (in collaboration with Clinical Operations TA Leads) to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
Identifies, recommends and drives changes in industry best practices and/or regulatory trends