TMF Specialist

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.

We need an Immediate Joiner for this role!!

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

• 2–3 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”

• 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

We need an Immediate Joiner for this role!!