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.

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