TMF Manager/ Document Specialist

eTMF completeness, accuracy, and inspection readiness

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

• 2–5+ 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