Clinical eTMF Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Artivion, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1984

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

Artivion, Inc. is a medical technology company focused on developing, manufacturing, and commercializing aortic- and cardiac-centric surgical devices and biomaterial products. The company produces heart valves (On-X), aortic arch and thoracoabdominal stent graft systems, hybrid prostheses (AMDS), cryopreserved allografts and tissues, surgical adhesives (BioGlue), and ancillary vascular and cardiac surgical tools. Artivion works with cardiac and vascular surgeons and conducts clinical trials and regulatory submissions to advance device safety and efficacy, serving hospitals and surgical centers globally.

📋 Description

• Manage and oversee the electronic Trial Master File (eTMF) throughout the clinical trial lifecycle • Ensure eTMF completeness, accuracy, compliance, and inspection readiness • Monitor eTMF quality metrics and address gaps or issues • Perform quality control checks and reconcile documents against the eTMF reference model • Coordinate with Clinical Operations, Quality Assurance, Regulatory Affairs, CROs, study sites, vendors, and cross-functional teams • Provide training and support on eTMF processes and best practices • Support regulatory inspections and sponsor audits • Identify and escalate compliance risks and document-related issues • Contribute to SOPs, work instructions, and training materials • Assist with system enhancements, upgrades, and user acceptance testing (UAT) • Complete other assigned functions

🎯 Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, or a related field (or equivalent experience) • Minimum of 2–4 years of experience in clinical trial documentation, TMF, or eTMF management • Solid understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements • Hands-on experience with eTMF systems (e.g., Florence, Veeva Vault, or similar) • Experience working TMF CDISC reference model and cross-functional clinical processes preferred • Strong attention to detail, organizational, and time management skills • Excellent written and oral communication and presentation skills • Excellent interpersonal skills and ability to work in a team-based, collaborative environment • Ability to independently plan, organize, coordinate, manage and execute assigned tasks and multiple projects • Willingness to travel • Good understanding of applicable regulations • Highly self-motivated, well organized, and confident • Possess a solution-oriented mindset and able to develop innovative solutions to issues

🏖️ Benefits

• Reasonable accommodation for applicants with disabilities • Willingness to travel is part of the role