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Etmf Jobs (NOW HIRING)

Sitero LLC

Director, Business Development

Miami, FL · On-site

The ideal candidate brings a proven track record of consultative selling within the eClinical ecosystem - whether EDC, RTSM, eTMF, CTMS, eConsent, or integrated clinical data platforms - and ...

ARTHREX

Clinical Study Manager

Naples, FL

Ensures compliance with the Clinical Trial Management System (CTMS), Electronic Trial Master (eTMF) filing, and Electronic Data Capture (EDC) systems, securing essential documents and quality ...

Sitero LLC

Director, Business Development

Miami, FL · On-site

The ideal candidate brings a proven track record of consultative selling within the eClinical ecosystem - whether EDC, RTSM, eTMF, CTMS, eConsent, or integrated clinical data platforms - and ...

MSD

Clinical Trial Coordinator (CTC) - Remote

Rahway, NJ · On-site

$68K - $107K/yr

Execute eTMF Quality Control Plan. * Update manuals/documents (e.g., patient diaries, instructions). * Document proper destruction of clinical supplies. * Prepare Investigator trial file binders.

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How much do etmf jobs pay per year?

As of Jul 2, 2026, the average yearly pay for etmf in the United States is $96,238.00, according to ZipRecruiter salary data. Most workers in this role earn between $86,000.00 and $109,500.00 per year, depending on experience, location, and employer.

What are the typical daily responsibilities of an eTMF Specialist?

As an eTMF Specialist, your daily responsibilities include managing, organizing, and maintaining essential clinical trial documents within the electronic Trial Master File system. You will monitor document completeness, track filing timelines, and ensure regulatory compliance, often collaborating with clinical, regulatory, and quality assurance teams. Regular audits, resolving document discrepancies, and training other team members on eTMF processes are also common tasks. The role requires staying up to date with changing regulatory requirements and maintaining clear communication with multiple stakeholders to support successful clinical trial operations.

What is an eTMF job?

An eTMF (electronic Trial Master File) job involves managing and maintaining digital documentation related to clinical trials. Professionals in this role ensure regulatory compliance, organize essential trial documents, and support inspection readiness. They may use eTMF systems to track, classify, and archive trial-related files. Strong attention to detail and knowledge of clinical research regulations are essential.

What are the key skills and qualifications needed to thrive in the Etmf position, and why are they important?

To thrive as an eTMF (electronic Trial Master File) Specialist, you need a strong understanding of clinical trial documentation, regulatory requirements, and document management best practices, often supported by a degree in life sciences or a related field. Familiarity with eTMF systems such as Veeva Vault or Medidata, as well as relevant certifications like the DIA TMF Certificate, is highly beneficial. Attention to detail, excellent organizational skills, and effective cross-functional communication make candidates stand out in this role. These competencies are crucial for ensuring that clinical trial documentation is complete, inspection-ready, and compliant with industry regulations.

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Etmf jobs near you

Clinical Operations Manager

Zydus Therapeutics

Pennington, NJ • On-site

Full-time

Posted 16 days ago

Job description

Job Type
Full-time
Description
Responsibilities:
  • Lead operational execution of assigned clinical trials under both:
    • In-house managed models (direct CRA/site oversight), and
    • Outsourced models (full-service or functional CRO partnerships)
  • Ensure consistent application of sponsor SOPs regardless of delivery model
  • Drive study start-up, enrollment, and close-out milestones across all regions
  • Directly manage CRAs and/or Lead CRAs assigned to in-house managed studies
  • Provide functional oversight of IHCRAs - Assign, prioritize, and track IHCRA work activities, including:

o Site document review and tracking
o Remote monitoring support and follow-up
o Query and action item tracking
o TMF/eTMF filing support and completeness checks
  • Review IHCRA outputs for quality, timeliness, and compliance
  • Provide feedback, coaching, and training input to IHCRAs in collaboration with line managers
  • Assign sites, review monitoring plans, and ensure adequate site coverage
  • Review monitoring visit reports, follow-up letters, and issue resolution
  • Coach and mentor CRAs to ensure monitoring quality and compliance
  • Provide sponsor oversight of CROs, vendors, and functional service providers
  • Review and approve CRO deliverables (monitoring plans, reports, metrics, TMF status)
  • Ensure CRO performance aligns with contracted scope, KPIs, timelines, and quality standards
  • Lead governance meetings, performance reviews, and escalation management
  • Ensure clear documentation of sponsor oversight activities per ICH E6(R2/R3)
  • Experience supporting and overseeing both Risk-Based Monitoring (RBM) strategies and traditional 100% SDV monitoring models, as appropriate to study design, risk profile, and regulatory expectations
  • Ability to transition studies between RBM and 100% SDV approaches based on protocol requirements, inspection feedback, or sponsor risk assessments
  • Oversight of monitoring plans to ensure:

o Appropriate SDV/SDR levels
o Centralized monitoring outputs are reviewed and actioned
o On-site, remote, and hybrid monitoring approaches are appropriately applied
  • Oversee protocol deviations, CAPAs, and quality issues
  • Identify operational risks early and implement mitigation strategies
  • Act as escalation point for complex site, CRA, or CRO issues
  • Partner with sites to support enrollment, retention, and protocol adherence
  • Ensure studies are inspection-ready at all times
  • Support and participate in regulatory inspections and audits (FDA, EMA, Health Authorities)
  • Ensure timely TMF completeness and eTMF oversight (in-house and CRO-maintained TMFs)
  • Collaborate with Clinical Development, Data Management, Biostatistics, Safety, Regulatory, and Supply Chain
  • Provide operational input into protocols, ICFs, feasibility, and country/site strategy
  • Support investigator meetings, site trainings, and study communications
  • Provide regular study status updates to senior management
  • Maintain oversight trackers, risk logs, issue logs, and KPI dashboards
  • Ensure accurate documentation of decisions, deviations, and actions
  • Any other duties as assigned by Supervisor.

Requirements
Qualifications
Education
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (required)
  • Advanced degree preferred

Experience
• 8+ years of clinical research experience, including management of both in-house and outsourced trials, with 6+ years of onsite monitoring CRA experience, including people management and CRO oversight exposure
  • Experience managing global or multi-regional Phase I-III trials preferred

Core Competencies & Skills
  • Strong understanding of sponsor oversight responsibilities under ICH-GCP
  • Hands-on experience with both direct CRA management and CRO governance
  • Expertise in RBM, centralized monitoring, and quality risk management
  • Strong leadership, communication, and stakeholder management skills
  • Ability to manage multiple studies and vendors simultaneously
  • Proficiency with CTMS, eTMF, and clinical systems

Preferred Experience
  • Sponsor-side experience in biotech or pharmaceutical companies
  • Experience transitioning studies between in-house and outsourced models
  • Experience in complex or rare disease trials
  • Prior inspection support experience

Travel
Up to 60% travel- Focused on co-monitoring, audit readiness visits, CRO oversight visits, inspections

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