Specialist, Regulatory

18 hours 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. Maintain inspection readiness for allocated studies; Quality, Compliance & Metadata

Validate document types, properties, indexing, and scanning quality against TMF readiness criteria and reference standards.

escalate risks/issues to the TMF Document Specialist Lead/TMF Operations as needed.

Operations, Training & Continuous Improvement

Deliver training/office hours for internal teams; Contribute to process improvements and special projects; 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.

~ Proven ability to run completeness reviews, manage EDL updates, and maintain inspection readiness .

~ Experience across Phase I–IV and multiple therapeutic areas.

experience building SOPs/work instructions.

completeness, timeliness, quality ).

Exposure to audit/inspection support (regulatory and sponsor).

Excel/Sheets for trackers & metrics).

Optional exposure: eCTD concepts, QMS, ETMF reporting/BI tools.

eTMF completeness % and quality error rate

Number of findings during internal QC/audits and regulatory inspections

Training adoption and stakeholder satisfaction

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