EvGen Governance Records & Systems Operations Lead

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description R ole Objective: As the first Data Governance & Systems Lead to join the Bengaluru GCM (Global Capability Model) , this role will focus on establishing and executing the governance records management and storage capability, ensuring that governance decisions, audit records, approvals, and exceptions are correctly uploaded, tagged, linked, and maintained to an audit-ready standard before broader repository and systems responsibilities are transitioned to the GCM . Over time, expand scope to cover the full range of data access, repository and systems maintenance activities including library validation, study systems oversight, and non-trial data management ​ . Key Accountabilities : I nitial Capability Build: Governance Records Maintenance & Repository ​ Upload governance records to the designated repository, applying naming conventions, metadata, access controls, and version history in line with defined standards and link to related documents for full traceability ​ Flag and track down missing or incomplete governance records; maintain the storage log to support ongoing governance and audit readiness; escalate unresolvable gaps to the Global Evidence Generation or Data Governance team ​ In the initial build phase, work closely with Global Evidence Generation and Data Governance teams to define and document the upload standards, naming conventions, metadata field requirements, retention categories, and escalation protocols that will govern all future archival activity ​ Upload records into the designated document management or contracting system, applying metadata, naming conventions, and access and retention rules in line with defined standards; link appropriate documents and flag any missing records ​ Maintain an update log and store system record history for traceability; escalate missing information, access issues, or non-standard records to Global Evidence Generation or the Data Owner for exception handling ​ Repository Validation & Quality Control ​ Run periodic validation checks across repositories for metadata completeness, broken links, access rules, versioning, and data entry standards; identify duplicates, outdated files, and missing metadata Correct administrative issues directly or request missing information from relevant owners Update validation logs and issue trackers following each review cycle; maintain validation evidence and review history for audit readiness Escalate substantive content changes, record ownership questions, or proposed changes with scientific integrity implications to Global Evidence Generation for review and approval ​ Study Systems Administration & Reporting ​ Maintain the central study repository structure; manage access permissions and version control across the portfolio of study-specific systems ​ Track and update study status across the portfolio in line with repository governance protocols defined by Global Evidence Generation ​ Generate standard repository reports and dashboards in line with reporting requirements and KPIs ​ Data Source Assessment & Evidence Documentation ​ Receive fit-for-purpose assessment requests and confirm study question , target population, endpoints, geography, intended use, and output format ​ Query approved candidate data sources, compile structured source inventories, and score candidates against agreed criteria (representativeness, completeness, date range, geography, access constraints, regulatory acceptability, quality) ​ Document strengths, limitations, gaps, assumptions, and constraints for each candidate source ​ Prepare assessment summaries, scorecards, inventories, and supporting documentation for US review; store completed materials, decisions, and rationale in the designated study evidence folder using consistent naming, metadata, versioning, and study linkage ​ Track assessment status, open questions, missing information, and overdue US decisions ​ Stakeholder Coordination & Escalation ​ Coordinate with Global Evidence Generation, RWD CoE , Data Governance, DD&T, I&A, LOCs, and data owners to clarify source availability, access constraints, and documentation requirements ​ Escalate unclear data limitations, source-selection tradeoffs, regulatory/payer relevance questions, and high-impact evidence concerns to US owners or Senior Manager ​ En