TMF Associate, TMF Center of Excellence

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Job Description

OBJECTIVES/PURPOSE:

• 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.

• Applies strong knowledge of TMF requirements, clinical trial processes, and document standards to ensure records are complete, accurate, consistent, and inspection-ready.

• Provides day-to-day operational guidance to TMF operations team, supports complex or escalated activities, and promotes consistent application of approved processes and standards.
• Drives operational efficiency and quality through risk identification, workflow improvement, standardization, automation, and data-informed oversight.

ACCOUNTABILITIES:

• Independently execute and coordinate eTMF document processing, classification, indexing, maintenance, reconciliation, and quality control activities in accordance with applicable SOPs, regulations, and study requirements.

• Perform and document second-line quality review of complex records and workflows to confirm completeness, accuracy, consistency, metadata quality, and compliance with established standards.

• Identify, investigate, and resolve record quality issues, metadata discrepancies, and workflow exceptions; escalate significant compliance risks through established channels.

• Perform effective periodic quality review, ensuring timely, accurate and complete records in adherence with applicable processes and regulations.

• Provide day-to-day guidance, peer support, and quality feedback to TMF and PV Documentation Excellence team to promote consistent execution and capability development.

• Maintain operational trackers, reports, and dashboards; analyze trends and support actions to improve quality, timeliness, productivity, and inspection readiness.

• Coordinate with study teams and cross-functional stakeholders to clarify requirements, resolve issues, manage priorities, and support compliant study delivery.

• Support inspection and audit readiness activities, including record retrieval, quality review, reconciliation, and timely response to documentation requests.

• Assess end-to-end records workflows and implement improvements across intake, review, approval, filing, retention, transfer, and archival activities.

• Lead or contribute to process standardization, simplification, automation, and system-enabled solutions that reduce manual effort and improve scalability.

• Contribute to controlled documents, job aids, training materials, knowledge resources, and operational procedures; deliver training or knowledge-sharing as assigned.

• Support testing, implementation, and adoption of process and technology enhancements, including automated document processing and quality controls.
• Lead defined work packages or continuous improvement initiatives, track deliverables, and communicate progress, risks, and decisions to relevant stakeholders.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Scientific or allied health/medical degree (BSc/BA) or equivalent experience.

• Typically 3+ years of experience in clinical research, TMF, records management, document management, or a related regulated environment.

• Hands-on experience with eTMF document processing, metadata, quality review, reconciliation, and inspection readiness activities.
• 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.
• 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.
• Experience with Veeva Vault eTMF or a comparable regulated content management system preferred.

• Ability to independently manage complex assignments, prioritize competing demands, and deliver high-quality work within established timelines.

• Demonstrated ability to investigate issues, assess risk, determine appropriate actions, and escalate significant concerns.

• Experience guiding peers, sharing knowledge, or supporting the training and onboarding of less-experienced colleagues.

• Strong analytical, organizational, problem-solving, and process improvement skills, with excellent attention to detail.

• Ability to interpret operational data and use metrics, trends, and quality findings to support decisions and improvements.

• Strong written, verbal, and interpersonal communication skills with the ability to collaborate effectively across global, cross-functional teams.

• Proficiency in Microsoft Office applications and skilled in adopting automation, analytics, and digital workflow tools.

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