TMF Specialist

2 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

  • TMF Operations Expert

    7 days ago

    Hyderabad, Telangana, India beBeeeTmf Full time ₹ 9,00,000 - ₹ 12,00,000

    TMF Expertise Specialist">Our team seeks a meticulous professional to oversee the completeness, accuracy, and inspection readiness of assigned studies within the eTMF environment.Maintain ongoing inspection readiness for allocated studies, focusing on Quality, Compliance, and Metadata. Ensure compliance with TMF readiness criteria and reference standards...

  • Senior Electronic Document Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeDocument Full time ₹ 90,00,000 - ₹ 1,50,00,000

    Senior Electronic Document Specialist Role OverviewWe are seeking an experienced and detail-driven professional to oversee the accuracy, integrity, and inspection readiness of electronic Trial Master Files (eTMFs) across assigned studies.Main Responsibilities:eTMF Reviews & ReadinessPerform comprehensive completeness checks in Veeva Vault, with cross-check...

  • Specialist, Regulatory

    1 week 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 ...

  • eTMF Regulatory Compliance Specialist

    1 day ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 6,00,000 - ₹ 8,00,000

    TMF Specialist - Regulatory ComplianceWe are seeking a meticulous TMF professional to ensure the completeness, accuracy, and inspection readiness of assigned studies across allocated projects.Maintain inspection readiness for allocated studies; ensuring quality, compliance, and metadata consistency.Validate document types, properties, indexing, and scanning...

  • Electronic Trial Master File Operations Expert

    7 days ago

    Hyderabad, Telangana, India beBeeTmf Full time ₹ 6,00,000 - ₹ 10,00,000

    TMF SpecialistThis is a highly rewarding role for a detail-obsessed professional with expertise in TMF/eTMF operations. The ideal candidate will own eTMF completeness, accuracy, and inspection readiness across assigned studies.Main Responsibilities:eTMF Reviews & Readiness The successful candidate will perform comprehensive completeness checks (periodic &...

  • Document Management Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeClinical Full time ₹ 30,00,000 - ₹ 40,00,000

    Clinical Document ManagementJob Overview:We are seeking a skilled Clinical Document Management specialist to drive the implementation of CDGM initiatives and projects.Key Responsibilities:Drive the planning and execution of migrations to and from enterprise clinical eDMS, aligning with business, compliance, and operational requirements.Partner with...

  • Project Specialist

    1 week ago

    Hyderabad, Telangana, India Syneos Health Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role & 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...

  • Senior Project Specialist

    1 week ago

    Hyderabad, Telangana, India Syneos Health Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Role & 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...

  • Clinical Data Associate II

    1 week ago

    Hyderabad, Telangana, India SDC (Statistics & Data Corporation) Full time ₹ 5,00,000 - ₹ 10,00,000 per year

    Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as...

  • TMF Specialist

    16 hours ago

    Hyderabad, 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...

  • TMF Specialist

    17 hours ago

    Hyderabad, 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...

  • TMF Specialist

    8 hours ago

    Hyderabad, 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+...

  • Specialist, Regulatory

    17 hours ago

    Hyderabad, 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....

  • Clinical Documents Expert

    5 days ago

    Pune, Chennai, Hyderabad / Secunderabad, Telangana, India beBeeClinical Full time

    TMF Specialist Job DescriptionWe are seeking a highly skilled

  • Clinical Documentation Specialist

    7 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeClinical Full time ₹ 15,00,000 - ₹ 28,00,000

    Job Title: Clinical Documentation ManagerJob DescriptionWe are seeking a skilled and experienced Clinical Documentation Manager to join our team. In this role, you will be responsible for managing clinical documentation for various projects, including in-licensing, out-licensing, acquisitions, and divestments.Key Responsibilities:Act as the point of contact...

  • Clinical Document Management Specialist

    7 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeClinical Full time ₹ 6,00,000 - ₹ 8,00,000

    Job Title: Clinical Documentation SpecialistAbout the RoleWe are seeking a highly skilled and experienced clinical documentation specialist to join our team. The ideal candidate will have a strong background in clinical document management, with experience in leading and planning migrations.Drive the implementation of CDGM initiatives, projects, and process...

  • Senior Clinical Document Specialist

    2 weeks ago

    Chennai, Hyderabad / Secunderabad, Telangana, Pune, India beBeeDocumentManagement Full time US$ 60,000 - US$ 1,20,000

    Job Title: Document Management Specialist">Process clinical study documents in accordance with client and project requirements, adhering to SOPs/WPs and relevant regulations.Liaise with project teams and other staff to ensure effective fulfillment of responsibilities.Complete assigned projects within specified timelines, ensuring adherence to regulatory...

  • Safety & Pharmacovigilance Specialist 1

    1 week ago

    Gurugram, Hyderabad, India Syneos Health Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Job Responsibilities:Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.Enters...

  • Spvg Scientific Spec Ii

    2 weeks ago

    Hyderabad, India Syneos Health Clinical Full time

    **SPVG Scientific Spec II - Literature Review** **-** **(** **22007651** **)** **Description** **SPVG Scientific Specialist II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around...