Senior Electronic Document Specialist

1 day ago

Hyderabad, Telangana, India beBeeDocument Full time ₹ 90,00,000 - ₹ 1,50,00,000
Senior Electronic Document Specialist Role Overview

We are seeking an experienced and detail-driven professional to oversee the accuracy, integrity, and inspection readiness of electronic Trial Master Files (eTMFs) across assigned studies.

Main Responsibilities:

  • eTMF Reviews & Readiness
  • Perform comprehensive completeness checks 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 Management

  • 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.

Essential Skills & 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 QUALIFICATIONS

  • 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).

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