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Job Description
OBJECTIVES/PURPOSE:
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Responsible for record generation, record processing, and second-line quality control activities supporting Clinical Trial Delivery and Pharmacovigilance Documentation Excellence records management and inspection readiness globally.
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Supports compliant, accurate, and efficient documentation processes across operational workflows across Takeda’s portfolio.
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Helps ensure records are complete, consistent, inspection-ready, and aligned with approved standards and business requirements.
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Contributes to operational efficiency through the reduction of manual effort and the implementation of more streamlined, standardized ways of working.
ACCOUNTABILITIES
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Execute eTMF study document processing, classification, indexing, and maintenance activities in compliance with applicable SOPs, regulations and study requirements.
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Perform second-line quality review to ensure record completeness, accuracy, consistency, and compliance with established standards and procedures.
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Identify record quality risks, metadata discrepancies, and workflow inefficiencies, and support timely resolution.
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Maintain operational reporting and tracking mechanisms to enable visibility, control, and performance monitoring.
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Support optimized end-to-end record workflows spanning intake, review, approval, filing, retention, and archival.
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Advance process efficiency through workflow simplification, standardization, and reduction of manual touchpoints.
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Drive adoption of automation, templated solutions, and system-enabled processing to enhance quality and scalability.
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Collaborate with cross-functional stakeholders to address questions, resolve issues, and provide operational support.
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Collaborate cross-functionally to align on priorities, requirements, escalations, and continuous improvement opportunities.
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Contribute to operational reports and dashboards to support continuous improvement and oversight.
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Recognize and appropriately escalate record-related issues, compliance risks, and workflow challenges through established channels.
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Contribute to process documentation, knowledge assets, training materials, and inspection readiness support.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
- 1+ year of experience in clinical research, TMF, and/or document management.
- Experience with Veeva Vault eTMF preferred
- Knowledge of applicable regulations and guidance (e.g., ICH E6 (R2/R3), 21 CFR Part 11, EU CTR as applicable, and EU GVP), with demonstrated application of ALCOA+ / data integrity and Good Documentation Practices.
- Proficient understanding of the DIA TMF Reference Model, TMF plans/Expected Document Lists (EDLs), and risk-based TMF QC/health check approaches to maintain continuous inspection readiness.
- Understanding of TMF management, compliance, and inspection readiness.
- Understanding of the clinical trial and drug development lifecycle.
- Strong organizational, time management, and prioritization skills.
- Excellent attention to detail and commitment to quality.
- Strong written, verbal, and interpersonal communication skills.
- Proficiency in Microsoft Office applications and skilled in adopting automation, analytics, and digital workflow tools.
- Ability to manage multiple tasks and meet deadlines.
- Strong problem-solving skills with a focus on process improvement and automation.
- Ability to work independently and collaborate effectively across teams.
Locations
IND - Bengaluru
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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