Sr. TMF Associate, TMF Center of Excellence

Takeda; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Takeda in Bengaluru is seeking an experienced TMF Records Manager to independently execute eTMF processing, QC, and inspection readiness across Takeda’s trials. You will apply rigorous ALCOA+ data integrity principles, mentor peers, and drive process improvements within a global TMF team.

The role requires 3+ years in TMF/records management, strong regulatory knowledge (ICH E6, Part 11), and hands-on eTMF experience. Excellent collaboration with cross-functional teams is essential.

Qualifications

• Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
• Typically 3+ years of experience in clinical research, TMF, records management, or a related regulated environment.
• Hands-on experience with eTMF document processing, metadata, quality review, reconciliation, and inspection readiness activities.

Responsibilities

• Independently execute and coordinate eTMF document processing, classification, indexing, maintenance, reconciliation, and quality control activities.
• Perform second-line quality review of complex records and workflows to confirm completeness, accuracy, consistency, and metadata quality.
• Identify, investigate, and resolve record quality issues, metadata discrepancies, and workflow exceptions; escalate significant compliance risks.
• Perform periodic quality reviews to ensure timely, accurate records and adherence to processes and regulations.
• Provide day-to-day guidance and quality feedback to TMF and PV Documentation Excellence teams.
• Maintain operational trackers, reports, and dashboards; analyze trends to improve quality, timeliness, productivity, and readiness.
• Coordinate with study teams and cross-functional stakeholders to resolve issues and support compliant study delivery.
• Support inspection and audit readiness activities, including record retrieval and timely responses to requests.
• Assess end-to-end records workflows and implement improvements across intake, review, filing, retention, transfer, and archival.
• Lead or contribute to process standardization, automation, and system-enabled solutions.

Skills

TMF records management

eTMF processing

Quality review

Regulatory knowledge

Veeva Vault

Education

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

Tools

Microsoft Office

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; escape 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 escape 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