EvGen Governance Records & Systems Operations Lead

Role Objective:

As the first Data Governance & Systems Lead to join the Bengaluru GCM(Global Capability Model)this role willfocus onestablishing and executing the governance records management and storagecapability ensuring that governance decisions audit records approvals andexceptions are correctly uploaded tagged linked and maintained to an audit-ready standard before broader repository and systems responsibilities aretransitioned to the GCM.

Over time expand scope to cover the full range of data access repository andsystems maintenance activities including library validation study systemsoversight and non-trial data management.

Key Accountabilities:

Initial Capability Build: GovernanceRecords Maintenance & Repository

• Upload governance records to the designated repository applying naming conventions metadata access controls and versionhistory in line with defined standards and link to related documents for full traceability

• Flag and track down missing or incomplete governance records;maintainthe storage log to support ongoing governance andaudit readiness; escalate unresolvable gaps to the Global Evidence Generation or Data Governance team

• In theinitialbuild phase work closely with Global Evidence Generation and Data Governance teams to define and document theupload standards naming conventions metadata field requirements retention categories and escalation protocols that willgovern allfuture archival activity

• Upload records into the designated document management or contracting system applying metadata naming conventions andaccess and retention rules in line with defined standards; linkappropriate documentsand 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for metadata completeness broken links access rules versioning and dataentry standards; identify duplicates outdated files and missing metadata Correct administrative issues directly or requestmissinginformation from relevant owners Update validation logs and issuetrackers following each review cycle; maintainvalidation evidence and review history for audit readiness Escalate substantive content changes record ownership questions orproposed changes withscientific 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 EvidenceGeneration

• 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 studyquestion target population endpoints geography intended useand 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 completedmaterials decisions and rationale in the designated study evidence folder using consistent naming metadata versioning andstudy linkage

• Track assessment status open questions missing information and overdue US decisions

Stakeholder Coordination & Escalation

• Coordinate with Global Evidence Generation RWDCoE Data Governance DD&T I&A LOCs and data owners to clarify sourceavailability access constraints and documentation requirements

• Escalate unclear data limitations source-selection tradeoffs regulatory/payer relevance questions and high-impact evidenceconcerns to US owners or Senior Manager

• Ensure limitations and gaps are clearly documented before sources are used for regulatory payer HTA or other high-impactevidence decisions

Qualifications:

Experience:>2 years of related work experience; >2 years of experience in the biopharmaceutical industry; experience in datagovernance repositorymanagement records management clinical data operations or a related documentation role at a pharmaceutical company or CROpreferred.

Technical skills:

• Experience managingdocumentor evidence repositories

• Working knowledge of governance record archival

• Ability to perform structured repository validation checks including metadata hygiene broken link identification duplicate recorddetection and version-control tracking

• Familiarity with study-specific systems used in clinical and evidence generation context

• Attention to detail with the ability to manage large volumes of records accurately and consistently across multiple concurrent workstreams

• Comfort with automation and AI-enabled tools in a data management or repository operations context

Education:A scientific medical life sciences or health economics degree is required

Languages:Fluent English;additionallanguagesadvantageous

Benefits

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

Competitive Salary Performance Annual Bonus

• Flexible work environment including hybrid working
• Comprehensive Healthcare Insurance Plans for self spouse and children
• Group Term Life Insurance and Group Accident Insurance programs
• Health & Wellness programs including annual health screening weekly health sessions for employees.
• Employee Assistance Program
• 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
• Broad Variety of learning platforms
• Diversity Equity and Inclusion Programs
• No Meeting Days
• Reimbursements Home Internet & Mobile Phone
• Employee Referral Program
• Leaves Paternity Leave (4 Weeks) Maternity Leave (up to 26 weeks) Bereavement Leave (5 days)

About ICC in Takeda

• Takeda is leading a digital revolution. Were not just transforming our company; were improving the lives of millions of patients who rely on our medicines every day.
• As an organization we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

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