Sr. TMF Associate, TMF Center of Excellence

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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 Takedas 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.