TMF Associate, TMF Center of Excellence

Takeda Pharmaceutical Co.; Bengaluru; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Takeda Pharmaceutical Co. in Bengaluru is seeking an organized professional to manage eTMF record processing, indexing, and quality control for Clinical Trial Documentation Excellence.

The role supports compliant, efficient documentation across our portfolio and drives automated, templated solutions to reduce manual touchpoints. The candidate will perform second-line quality reviews, identify risks, maintain dashboards, and collaborate with stakeholders to ensure inspection readiness and

Qualifications

• 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 ICH E6 (R2/R3), 21 CFR Part 11, EU CTR, EU GVP.
• Understanding of TMF management, compliance, and inspection readiness.
• Proficient with DIA TMF Reference Model, TMF plans/EDLs, and risk-based TMF QC/health check approaches.

Responsibilities

• Execute eTMF study document processing, classification, indexing, and maintenance activities in compliance with SOPs and study requirements.
• Perform second-line quality review to ensure record completeness, accuracy, consistency, and compliance with standards and procedures.
• Identify record quality risks, metadata discrepancies, and workflow inefficiencies, and support timely resolution.
• Maintain operational reporting and tracking mechanisms for visibility, control, and performance monitoring.
• Support end-to-end record workflows spanning intake, review, approval, filing, retention, and archival.
• Advance process efficiency through workflow simplification, standardization, and automation.
• Drive adoption of automation, templated solutions, and system-enabled processing to enhance quality and scalability.
• Collaborate with cross-functional stakeholders to address questions and escalate issues.
• Contribute to process documentation, knowledge assets, training materials, and inspection readiness.

Skills

Organizational skills

Time management

Prioritization

Attention to detail

Communication (written & verbal)

Microsoft Office proficiency

Automation & analytics

Digital workflow tools

multitasking

Education

BSc/BA in science or allied health

Tools

Veeva Vault eTMF

Microsoft Office

Job description

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 escal…

• 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