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Job Description
OBJECTIVES/PURPOSE:
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Responsible for independently executing and coordinating TMF and PV records management activities, including eTMF processing, second-line quality control, quality review, issue resolution, and TMF inspection readiness across Takeda’s global portfolio.
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Applies strong knowledge of TMF requirements, clinical trial processes, and document standards to ensure records are complete, accurate, consistent, and inspection-ready.
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Provides day-to-day operational guidance to TMF operations team, supports complex or escalated activities, and promotes consistent application of approved processes and standards.
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Drives operational efficiency and quality through risk identification, workflow improvement, standardization, automation, and data-informed oversight.
ACCOUNTABILITIES:
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Independently execute and coordinate eTMF document processing, classification, indexing, maintenance, reconciliation, and quality control activities in accordance with applicable SOPs, regulations, and study requirements.
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Perform and document second-line quality review of complex records and workflows to confirm completeness, accuracy, consistency, metadata quality, and compliance with established standards.
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Identify, investigate, and resolve record quality issues, metadata discrepancies, and workflow exceptions; escalate significant compliance risks through established channels.
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Perform effective periodic quality review, ensuring timely, accurate and complete records in adherence with applicable processes and regulations.
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Provide day-to-day guidance, peer support, and quality feedback to TMF and PV Documentation Excellence team to promote consistent execution and capability development.
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Maintain operational trackers, reports, and dashboards; analyze trends and support actions to improve quality, timeliness, productivity, and inspection readiness.
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Coordinate with study teams and cross-functional stakeholders to clarify requirements, resolve issues, manage priorities, and support compliant study delivery.
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Support inspection and audit readiness activities, including record retrieval, quality review, reconciliation, and timely response to documentation requests.
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Assess end-to-end records workflows and implement improvements across intake, review, approval, filing, retention, transfer, and archival activities.
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Lead or contribute to process standardization, simplification, automation, and system-enabled solutions that reduce manual effort and improve scalability.
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Contribute to controlled documents, job aids, training materials, knowledge resources, and operational procedures; deliver training or knowledge-sharing as assigned.
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Support testing, implementation, and adoption of process and technology enhancements, including automated document processing and quality controls.
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Lead defined work packages or continuous improvement initiatives, track deliverables, and communicate progress, risks, and decisions to relevant stakeholders.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
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Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
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Typically 3+ years of experience in clinical research, TMF, records management, document management, or a related regulated environment.
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Hands-on experience with eTMF document processing, metadata, quality review, reconciliation, and inspection readiness activities.
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Strong 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.
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Strong 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.
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Experience with Veeva Vault eTMF or a comparable regulated content management system preferred.
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Ability to independently manage complex assignments, prioritize competing demands, and deliver high-quality work within established timelines.
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Demonstrated ability to investigate issues, assess risk, determine appropriate actions, and escalate significant concerns.
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Experience guiding peers, sharing knowledge, or supporting the training and onboarding of less-experienced colleagues.
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Strong analytical, organizational, problem-solving, and process improvement skills, with excellent attention to detail.
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Ability to interpret operational data and use metrics, trends, and quality findings to support decisions and improvements.
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Strong written, verbal, and interpersonal communication skills with the ability to collaborate effectively across global, cross-functional teams.
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Proficiency in Microsoft Office applications and skilled in adopting automation, analytics, and digital workflow tools.
Locations
IND - Bengaluru
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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