Trial Operations Data Analyst

Role Description

Support Trial Operations data governance by performing manual stewardship review for the Trial Ops MDM domain, ensuring master data is accurate, complete, and fit-for-use across downstream consumption.

• Partner with Trial Ops Governance, Data Owners/Stewards, and operational stakeholders to apply approved data standards and business rules consistently during create/change requests.
• Improve and sustain data quality and integrity for Trial Ops master data through timely review, issue identification, and escalation, contributing to audit-ready governance and efficient trial execution.

Accountabilities

• Perform manual review and validation of Trial Ops MDM records (new/updates) against defined standards (naming conventions, required attributes, allowed values, uniqueness/duplication, reference integrity, and lifecycle status).
• Triage, investigate, and resolve basic data quality issues (missing/invalid attributes, duplicates, conflicting sources) and route complex exceptions to the appropriate Data Steward/Data Owner with clear evidence and recommendation.
• Execute stewardship workflows in the designated tools (intake queue, workflow/MDM platform, ticketing), ensuring each request is processed within agreed SLAs and status is kept current.
• Document decisions and rationale for approvals/rejections/holds in alignment with Takeda governance practices, maintaining an audit trail for stewardship actions.
• Apply data governance policies (domain definitions, critical data elements, data quality rules, reference data usage, and change control) and ensure adherence to Takeda Quality Management System (QMS) and relevant procedures.
• Monitor and report on operational metrics (volume, turnaround time, defect themes, rework drivers), escalating emerging risks/trends and proposing practical remediation steps.
• Support data cleansing and remediation activities (duplicate resolution, standardization, backlog reduction) under the direction of the domain steward/governance lead.
• Coordinate with cross-functional teams (e.g., Trial Ops, Study Start-up, Vendor/Systems teams, Data Governance) to clarify requests, obtain missing information, and prevent recurring data issues.
• Contribute to continuous improvement by identifying opportunities to streamline manual review steps, update checklists/job aids, refine business rules, and improve upstream data capture.
• Maintain required training and compliance for systems access, data handling, and SOPs; handle sensitive information appropriately and consistently with Takeda policies.

Qualifications

• Bachelor’s degree (or international equivalent) preferred; equivalent experience considered.
• 2+ years in data stewardship/MDM/data quality or related data operations (life sciences/clinical trial ops preferred).
• Experience working in SOP/quality-controlled or regulated (GxP) environments preferred.
• Detail-oriented; quality-first and accountable.
• Sound judgment; escalates appropriately.
• Clear communicator; collaborative in a matrixed environment.
• Organized; able to meet SLAs in a high-volume workflow.
• Continuous improvement mindset.
• Working knowledge of data governance and data quality concepts.
• Ability to apply standards/rules for manual review (completeness, validity, duplicate checks).
• Proficient in Excel and collaboration tools; comfortable with ticketing/workflow and MDM systems.
• Basic reporting/metrics and strong documentation/audit-trail discipline.
• Awareness of GxP and 21 CFR Part 11 expectations.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.