TMF Associate, TMF Center of Excellence

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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.

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