Sr. TMF Associate, TMF Center of Excellence

Takeda Pharmaceutical Co.; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a TMF and PV records management expert to independently execute and coordinate eTMF processing, quality control, and inspection readiness across Takeda's global portfolio.

You will apply solid knowledge of TMF standards and regulatory requirements to maintain complete, accurate, and audit-ready records. You will lead day-to-day guidance for the TMF operations team, drive process improvements, coordinate with cross-functional study teams, and support testing

Qualifications

• BSc/BA in science or related field, or equivalent experience.
• 3+ years in clinical research, TMF, records management, or regulated environment.
• Hands-on experience with eTMF document processing, metadata, quality review, reconciliation, and inspection readiness.
• Knowledge of ICH E6, 21 CFR Part 11, EU CTR, EU GVP; data integrity and Good Documentation Practices.

Responsibilities

• Execute and coordinate eTMF processing, classification, indexing, maintenance and quality control.
• Perform second-line quality review of complex records and workflows for accuracy and compliance.
• Identify, investigate, and resolve record quality issues; escalate risks per process.
• Maintain operational trackers, reports and dashboards; analyze trends to improve quality and inspection readiness.
• Coordinate with study teams and cross-functional stakeholders to clarify requirements and priorities.
• Support inspection readiness activities, including document retrieval and timely responses.
• Lead process standardization, automation, and system-enabled improvements.

Skills

TMF records management

eTMF processing

Quality review

Regulatory compliance

ALCOA+ / data integrity

Veeva Vault eTMF

Cross-functional collaboration

Data analysis

Microsoft Office

Automation tooling

Education

BSc/BA in science or related field

Tools

Veeva Vault eTMF

Quality management systems

Job description

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; elevate 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 escalation 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.

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time