Tmf specialist
4 weeks 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
3 weeks ago
Hyderabad, India Tilda Research Full timeJob Description 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...
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TMF Document Specialist
2 days ago
Greater Hyderabad Area, India Tilda Research Full time ₹ 5,00,000 - ₹ 12,00,000 per yearPosition OverviewWe are seeking aTMF Document Specialistwith 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...
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Project Specialist
4 weeks ago
Hyderabad, India Syneos Health Full timeRole & responsibilities: Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. Attends, participates, prepares and...
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Senior Project Specialist
4 weeks ago
Hyderabad, India Syneos Health Full timeRole & responsibilities: Set-up, maintain and close out project files and study information ((e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. Maintain and...
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Clinical Trial Project Specialist
4 days ago
Hyderabad, India Imaging Endpoints Full timeSUMMARYImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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Clinical Research Documentation Specialist
6 days ago
Ameerpet, Hyderabad, Telangana, India Forward Life Pvt. Ltd Full time ₹ 2,64,000 per yearRole Overview:The Clinical Research Documentation Specialist supporting the Head of the Ethics Committee (EC) Division plays a key role in ensuring all documentation is accurate, compliant, and audit-ready. This position requires managing end-to-end responsibilities related to clinical research documentation in alignment with regulatory, institutional, and...
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Hyderabad, India Imaging Endpoints Full timeSUMMARY Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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Hyderabad, India Imaging Endpoints Full timeSUMMARY Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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Hyderabad, India Imaging Endpoints Full timeSUMMARY Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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Hyderabad, India Imaging Endpoints Full timeSUMMARY Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
