EvGen Governance Records & Systems Operations Lead
Bengaluru, Karnataka Job ID R0187213 Category Data Sciences Subcategory Research & Development Business Unit Global Portfolio Division Job Type Full timeBy 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
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: 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;maintainthe storage log to support ongoing governance and audit 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 the upload standards, naming conventions, metadata field requirements, retention categories, and escalation protocols that will govern allfuture 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; 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 data entry standards; identify duplicates, outdated files, and missing metadata Correct administrative issues directly or request missinginformation from relevant owners Update validation logs and issuetrackers following each review cycle; maintain validation evidence and review history for audit readiness Escalate substantive content changes, record ownership questions, or proposed 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 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 studyquestion, 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
Ensure limitations and gaps are clearly documented before sources are used for regulatory, payer, HTA, or other high-impact evidence 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 Englishrequired;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. We’re not just transforming our company; we’re 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.
Locations
IND - Bengaluru
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Locations
IND - Bengaluru - Research and Development
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Locations
IND - Bengaluru - Research and DevelopmentWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
