Seemab Ahmad

About Seemab Ahmad

I am a seasoned Clinical Document & TMF Reviewer with proven expertise in managing Trial Master File (eTMF) operations, regulatory compliance, and audit readiness across global biopharmaceutical studies. With hands-on experience in Veeva Vault eTMF and other leading platforms, I ensure quality, consistency, and inspection readiness for high-stakes clinical trials.My approach blends deep domain knowledge,stakeholder engagement, and technology-driven process optimization to deliver high-performing TMF ecosystems. I’ve partnered with sponsors and driving successful outcomes across diverse therapeutic areas and study phases. Clinical Document Management & TMF Oversight • Led TMF milestone and periodic reviews across sponsor platforms including AstraZeneca, Genfit, Apilis, and more. • Ensured audit-readiness through RBQC, metadata verification, completeness checks, and cross-referencing. • Oversaw ICF, IRB, and regulatory submissions accuracy to maintain document integrity. Regulatory Compliance & Quality Control • Conducted CAPA responses, co-dependency checks, and CTMS verification (Trip & Contact Reports). • Maintained alignment with ICH-GCP, sponsor SOPs, and global compliance standards. • Proactively identified TMF quality risks and escalated emerging trends. Stakeholder Collaboration & Oversight • Facilitated TMF-specific kickoff meetings and drove alignment with sponsors and cross-functional teams. • Supported audit and inspection prep, ensuring a continuous state of readiness. • Successfully led MSD Merck FSPx unblinded study (95+ protocols) as TMF SME. Process Optimization & Automation • Spearheaded TMF automation initiatives to streamline metadata consistency and quality control. • Planned and executed study start-up, audit timelines, and client engagement strategies. • Delivered scalable improvements in document workflow and compliance tracking. Technical Proficiency • Platforms: Veeva Vault eTMF, Chiltern ePS, Siebel CTMS • Tools: Smart Inbox, EDL Tailoring & Updates, Risk-Based QC, ARC Reviews, Placeholder Creation • TMF Analytics: Completeness & Requiredness Checks, Inspection Readiness, Metadata Audits. I thrive in dynamic, compliance-driven environments where quality, collaboration, and proactive problem-solving drive success. If you’re looking for a strategic TMF partner or documentation SME, let’s connect.

Experience

1. Tmf Reviewer Ii

   Fortrea

   Apr 2026 — Present · Bengaluru, IN

   TMF Management & Compliance: Veeva Vault eTMF, Periodic & Milestone Reviews, Completeness Check, Requiredness Check, EDL Tailoring & Updates, Risk-Based Quality Check (RBQC), Inspection Readiness, CAPA Response, Audit & Inspection Preparation.Regulatory & Document Control: Metadata Verification, Document Tracking & Filing (Smart Inbox), Co-Dependency Checks, CTMS Verification (Trip & Contact Reports), ARC Review, Reclassification, Missing Document Management (Placeholder Creation)Process Optimization & Automation: Automation Tools, TMF-Specific Kickoff Meetings, Study Planning, Audit Planning, Client Engagement, Cross-Referencing & Quality AssuranceStakeholder Collaboration & Oversight: Conducting Client Meetings, Compliance with SOPs & ICH Guidelines, Business Process Improvement, Operational Issue Resolution, Status Reporting, TMF Readiness & maintenance.Clinical Document Management & TMF Oversight • Lead TMF milestone reviews and periodic assessments across multiple sponsor platforms, including AstraZeneca, Cytokinetics, Biomea, Genfit, IPSEN, Apilis, and BMS. • Ensure audit-ready documentation by conducting quality and content reviews (RBQC), metadata verification, and TMF completeness checks. • Perform cross-referencing procedures to ensure accuracy in ICFs, IRB authorizations, and submissions. Regulatory Compliance & Risk-Based Quality Control• Conduct CAPA responses, co-dependency checks, and verification against CTMS reports.• Maintain TMF compliance with ICH-GCP guidelines, organizational SOPs, and sponsor requirements.• Identify and resolve TMF content quality issues while proactively alerting management to emerging trends. Stakeholder Coordination & Process Improvement • Facilitate TMF-specific kickoff meetings with sponsors and project teams to establish expectations.• Support audit and inspection preparation. Technology & Automation IntegrationExpertise in Veeva Vault eTMF, Chiltern eTMF (ePS), and Siebel CTMS ensuring seamles

Education

• Patna University

  Master of Science, Biochemistry

  2016 — 2018

• Punjab Technical University

  Bsc, Biotechnology

  2011 — 2014