Senior Role - Clinical Data Standards

- Manage a global team of Clinical Data Standards Specialists providing operational, technical and strategic management and development of teams.

- Accountable for all aspects of Clinical Data Standards delivery within assigned discipline including the strategy and planning to ensure the successful development and maintenance of end-to-end s data and reporting standards in one or more disciplines of data acquisition and tabulation, analysis and reporting and/or regulatory data submission across multiple disease/therapeutic areas and drug development phases.

- In collaboration with stakeholder and partner functions, accountable for driving standards implementation across the organization and defines and monitor KPIs/metrics, strategies, frameworks, policies, business rules and processes for development, maintenance, deployment and adoption with a solid focus on scientific and regulatory needs.

- Lead the technical review and assessment of industry and regulatory standards and technologies supporting regular gap/impact analysis and implementation of action plans where needed.

- Act as an expert consultant /SME providing Clinical Data Standards input to all relevant areas including; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems.

- May also represent at internal and external decision boards and deputise for Head CDS as required.