By 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 OBJECTIVES/PURPOSE: • 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. • Supports compliant, accurate, and efficient documentation processes across operational workflows across Takeda’s portfolio. • Helps ensure records are complete, consistent, inspection-ready, and aligned with approved standards and business requirements. • Contributes to operational efficiency through the reduction of manual effort and the implementation of more streamlined, standardized ways of working. • ACCOUNTABILITIES • Execute eTMF study document processing, classification, indexing, and maintenance activities in compliance with applicable SOPs, regulations and study requirements. • Perform second-line quality review to ensure record completeness, accuracy, consistency, and compliance with established standards and procedures. • Identify record quality risks, metadata discrepancies, and workflow inefficiencies, and support timely resolution. • Maintain operational reporting and tracking mechanisms to enable visibility, control, and performance monitoring. • Support optimized end-to-end record workflows spanning intake, review, approval, filing, retention, and archival. • Advance process efficiency through workflow simplification, standardization, and reduction of manual touchpoints. • Drive adoption of automation, templated solutions, and system-enabled processing to enhance quality and scalability. • Collaborate with cross-functional stakeholders to address questions, resolve issues, and provide operational support. • Collaborate cross-functionally to align on priorities, requirements, escalations, and continuous improvement opportunities. • Contribute to operational reports and dashboards to support continuous improvement and oversight. • Recognize and appropriately escalate record-related issues, compliance risks, and workflow challenges through established channels. • 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