TMF Lead, TMF Center of Excellence, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence
Takeda · Bengaluru
Job Description
OBJECTIVES/PURPOSE:
- Oversee the management, maintenance and compliance of TMF and PV records management operations in the TMF Center of Excellence global capability center
- Applies strong knowledge of TMF requirements, clinical trial processes, and document standards to ensure records are complete, accurate, consistent, and inspection-ready.
- Provides development, training and operational guidance to staff, supports complex or escalated activities, and ensures consistent application of approved processes and standards.
- Drives operational efficiency and quality through risk identification, workflow improvement, standardization, automation, and data-informed oversight.
ACCOUNTABILITIES
- Lead day-to-day TMF and PV records management operations within the TMF Center of Excellence Global Capability Center, ensuring timely, accurate, and compliant execution of document processing, filing, indexing, quality review, and records support activities.
- Provide people leadership, coaching, workload management, and performance oversight for a team of TMF Associates supporting global TMF and PV documentation operations.
- Ensure TMF and PV records activities support inspection readiness through complete, accurate, reliable, and retrievable records maintained throughout the record lifecycle.
- Monitor team delivery against quality, productivity, service, and compliance expectations, and implement actions to address gaps and improve operational performance across the capability center.
- Conducts quality review, TMF health checks and monitors KPI in collaboration with the study team for complex and business critical studies
- Partner with study teams and cross-functional stakeholders to support TMF and PV records management operations, including issue resolution, escalations, and delivery against operational priorities.
- Drive consistent application of records management standards, expected document requirements, taxonomy, metadata quality, and quality control practices across TMF Center of Excellence activities.
- Review operational trends, quality signals, and recurring issues to identify risks, strengthen controls, and improve consistency across TMF and PV records operations.
- Support inspection readiness activities, audits, document retrieval, and remediation efforts related to TMF and PV documentation.
- Contribute to standardization, simplification, and workflow optimization across TMF and PV records management operations to reduce manual effort and improve scalability.
- Support implementation of process, reporting, and technology enhancements, including automation and digital solutions relevant to TMF and PV documentation operations.
- Maintain effective collaboration escalate risks, resource constraints, and operational issues as appropriate within the TMF Center of Excellence Global Capability Center.
- Contribute to training, onboarding, knowledge sharing, and capability development to strengthen TMF and PV records management operations.
- Foster a culture of quality, accountability, customer focus, continuous improvement, and compliance across the TMF Center of Excellence Global Capability Center.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Scientific or allied health/medical degree (BSc/BA) or equivalent experience.
- Typically 5+ years of experience in clinical research, TMF, records management, document management, or a related regulated environment.
- Hands-on experience with eTMF (Veeva preferred) 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.
- 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.