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 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:  

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; 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for metadata completeness, broken links, access rules, versioning, and data entry standards; identify duplicates, outdated files, and missing metadata Correct administrative issues directly or request missing information from relevant owners Update validation logs and issue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​ 

• 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 data governance, repository management, records management, clinical data operations, or a related documentation role at a pharmaceutical company or CRO preferred​. 

Technical skills:​ 

• Experience managing document or evidence repositories​ 

• Working knowledge of governance record archival​ 

• Ability to perform structured repository validation checks including metadata hygiene, broken link identification, duplicate record detection, 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 required; additional languages advantageous 

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.

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