Only 24h Left) TMF Specialist

4 weeks ago

Hyderabad, Telangana, India Tilda Research Full time
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

- 2–5+ 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

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