Tmf specialist
4 days ago
We’re looking for a detail-obsessed TMF professional to own e TMF 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 e TMF 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/e TMF operations within clinical research (CRO, sponsor, or TMF service provider). Hands-on experience with Veeva Vault e TMF (or similar e TMF), 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 e TMF (primary), plus standard productivity tools (e.g., Excel/Sheets for trackers & metrics). Optional exposure: e CTD concepts, QMS, ETMF reporting/BI tools. Success Metrics (KPIs) e TMF 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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TMF Specialist
1 week ago
Hyderabad, India Tilda Research Full timeWe’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...
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TMF Specialist
1 week ago
Hyderabad, India Tilda Research Full timeWe’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+...
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TMF Specialist
3 weeks ago
Hyderabad, Telangana, India Tilda Research Full timeWe'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...
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TMF Specialist
1 week ago
Hyderabad, India Tilda Research Full timeWe’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...
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TMF Specialist
1 week ago
Hyderabad, India Tilda Research Full timeWe’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+...
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TMF Specialist
1 week ago
Hyderabad, India Tilda Research Full timeWe’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+...
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TMF Specialist
1 week ago
hyderabad, India Tilda Research Full timeWe’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+...
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TMF Specialist
1 week ago
Hyderabad, India Tilda Research Full timeWe’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+...
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Only 24h Left) TMF Specialist
3 weeks ago
Hyderabad, Telangana, India Tilda Research Full timeWe'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...
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Specialist, Regulatory
1 week ago
Hyderabad, India Tilda Research Full timeWe’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....
