TMF Lead

Tilda Research Inc.; India; On-site; INR 1,600,000 - 2,600,000; Full time

Job summary

Tilda Research Inc. seeks a detail-obsessed TMF Lead to own eTMF completeness, accuracy, and inspection readiness across studies. You will run periodic and milestone reviews in Veeva Vault, identify gaps, and partner with Study Teams and TMF Leads to keep the file audit-ready.

ALCOA+ and metadata checks should be second nature as you coach others on TMF best practices. You will ensure document types, indexing, and scanning quality meet TMF readiness criteria, while advancing training and process

Qualifications

• 4+ years in TMF/eTMF operations within clinical research.
• Hands-on experience with Veeva Vault eTMF including ingestion, indexing, QC and reporting.
• Strong knowledge of ICH-GCP, ALCOA+ and TMF Reference Model concepts.
• Proven ability to run completeness reviews, update EDL, and maintain inspection readiness.
• Excellent attention to detail, organization and stakeholder communication; able to escalate as needed.
• Ability to meet SLAs across multiple studies in a deadline-driven environment.

Responsibilities

• eTMF reviews and readiness across assigned studies with cross-checks for dependencies.
• Perform completeness checks (periodic and milestone) in Veeva Vault and reconcile gaps.
• Maintain inspection readiness and close missing/errant documents.
• Update the Expected Document List (EDL) as requirements change.
• Collaborate with Study Teams, TMF Leads, and Document Owners to resolve discrepancies.
• Follow up with stakeholders to close actions within SLAs and escalate risks when needed.
• Deliver TMF process training and support continuous improvement initiatives.

Skills

eTMF completeness

Veeva Vault

ALCOA+

ICH-GCP

TMF Reference Model

EDL updates

Attention to detail

Stakeholder communication

Tools

Veeva Vault eTMF

Excel/Sheets

Job description

TMF Lead

We’re looking for a detail-obsessed TMF professional to own eTMF completeness, accuracy, and inspection readiness across assigned studies. You’ll run periodic/milestone reviews in Veeva Vault , identify and resolve gaps (including co-dependencies), and partner closely with Study Teams and the TMF Lead to keep the file audit-ready at all times. If ALCOA+ and metadata checks are second nature to you and you enjoy coaching others on best practices, this role is for you.

Key Responsibilities

• eTMF Reviews & Readiness
• Perform comprehensive completeness checks (periodic & milestone) in Veeva Vault, with cross-check and co-dependency verification.
• Maintain inspection readiness for allocated studies; proactively identify and close missing/errant documents.
• Update and maintain the Expected Document List (EDL) as requirements change.
• Quality, Compliance & Metadata
• Execute ALCOA+ and metadata checks to ensure accuracy, integrity, and compliance with GCP and internal SOPs.
• Validate document types, properties, indexing, and scanning quality against TMF readiness criteria and reference standards.
• Collaboration & Issue Resolution
• Partner with Study Teams , TMF Leads , Document Owners, and TMF Study Owners to gather requirements and resolve discrepancies.
• Follow up with stakeholders to close action items within agreed SLAs; escalate risks/issues to the TMF Document Specialist Lead/TMF Operations as needed.
• Communicate document inquiries with responsible users and provide clear guidance on corrective actions.
• Operations, Training & Continuous Improvement
• Process TMF documents per good documentation practices and study priority/criticality within timelines.
• Deliver training/office hours for internal teams; respond to TMF process and system queries.
• Contribute to process improvements and special projects; serve as an SME for TMF processes, systems, and tools where applicable.

Required Qualifications

• 4 + years in TMF/eTMF operations within clinical research (CRO, sponsor, or TMF service provider).
• Hands-on experience with Veeva Vault eTMF (or similar eTMF), including document ingestion, indexing, QC, and reporting.
• Strong working knowledge of ICH-GCP , ALCOA+ , and TMF Reference Model concepts.
• Proven ability to run completeness reviews, manage EDL updates, and maintain inspection readiness.
• Excellent attention to detail, organization, and stakeholder communication; comfortable escalating appropriately.
• Ability to work to SLAs , juggle multiple studies, and deliver in a deadline-driven environment.

Preferred/"Nice to Have"

• Ultilized AI in your day to day / Drive to want to build their AI Skillset
• Experience across Phase I–IV and multiple therapeutic areas.
• Prior role as TMF SME/Trainer ; experience building SOPs/work instructions.
• Familiarity with TMF metrics and dashboards (e.g., completeness, timeliness, quality ).
• Exposure to audit/inspection support (regulatory and sponsor).

Tools & Systems

• Veeva Vault eTMF (primary), plus standard productivity tools (e.g., Excel/Sheets for trackers & metrics).
• Optional exposure: eCTD concepts, QMS, ETMF reporting/BI tools.

Success Metrics (KPIs)

• eTMF completeness % and quality error rate
• On-time document processing against SLA
• Aging of open queries/action items
• Number of findings during internal QC/audits and regulatory inspections
• Training adoption and stakeholder satisfaction