TMF Document Specialist

2 days ago

Greater Hyderabad Area, India Tilda Research Full time ₹ 5,00,000 - ₹ 12,00,000 per year

Position Overview

We are seeking a
TMF Document Specialist
with strong expertise in eTMF systems (preferably Veeva Vault) to ensure inspection readiness, completeness, and compliance of clinical trial documentation. The ideal candidate will be detail-oriented, process-driven, and experienced in document quality control, cross-checks, and metadata validation within clinical trial environments.

Key Responsibilities

  • Perform comprehensive eTMF completeness checks, milestone reviews, cross-checks, and co-dependency checks to identify missing or inconsistent documents in Veeva Vault.
  • Maintain inspection readiness for allocated studies, ensuring adherence to SOPs, regulatory requirements, and industry standards.
  • Conduct ALCOA+E and metadata checks to ensure accuracy, integrity, and compliance.
  • Update and maintain the Expected Document List (EDL) as required.
  • Collaborate with TMF Leads and study teams to collect requirements for review, follow up on action items, and close outstanding issues.
  • Provide training, mentorship, and support to internal team members; respond to TMF process or system queries.
  • Process TMF documents in line with good documentation practices, indexing requirements, and TMF readiness criteria.
  • Communicate with Document Owners, TMF Study Owners, and end users to resolve discrepancies and escalate issues when needed.
  • Deliver work within established SLAs and agreed timelines, ensuring critical documents are processed based on priority.
  • Contribute to process improvements, initiatives, and projects to enhance TMF quality and compliance.
  • Serve as a Subject Matter Expert (SME) for TMF processes, systems, and related tools when applicable.

Qualifications & Skills

  • Bachelor's degree in Life Sciences, Clinical Research, or related field (or equivalent experience).
  • 2–5 years of experience in TMF management, clinical documentation, or records management within the pharmaceutical/clinical research industry.
  • Hands-on experience with
    eTMF systems
    , preferably
    Veeva Vault
    .
  • Strong knowledge of TMF document types, properties, indexing, and expected document lists (EDLs).
  • Familiarity with
    ALCOA+E principles
    , metadata checks, and regulatory compliance requirements (ICH GCP, FDA, EMA).
  • Excellent attention to detail and ability to identify document gaps and compliance risks.
  • Strong organizational, communication, and problem-solving skills.
  • Ability to work independently and collaboratively with cross-functional teams.

Why Join Us

  • Opportunity to work in a highly collaborative, compliance-driven environment.
  • Gain hands-on expertise with leading eTMF systems and inspection readiness processes.

Contribute to high-impact clinical trial operations supporting global regulatory submissions.

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