Senior Clinical Research Associate – EU, Medical Devices

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🔥 0 minutes ago

🌐 Switzerland, Germany, +1 more countries – Remote

🇨🇭 Switzerland – Remote 🇩🇪 Germany – Remote 🇫🇷 France – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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.

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Anteris Technologies

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2006

🏥 Healthcare

🔧 Hardware

Healthcare • Hardware

Anteris Technologies is a medical technology company focused on developing next-generation transcatheter heart valve solutions to treat aortic stenosis. The company’s lead product, the DurAVR® Transcatheter Heart Valve (THV), is a single-piece, native-shaped biomimetic valve designed to mimic healthy aortic valve physiology and restore laminar flow. Anteris emphasizes science-driven, measurable improvements in cardiac outcomes, citing early clinical and retrospective analyses (EMBARK, EFS, PARADIGM and investigator-led studies) reporting favorable hemodynamics, reduced patient-prosthesis mismatch, and promising short-term safety signals. DurAVR® is currently available for investigational use only while the company pursues regulatory approvals and broader clinical evaluation. Anteris also engages with the medical community through presentations, webinars, and investigator-sponsored research to build clinical evidence for its biomimetic TAVR approach.

📋 Description

• Oversee CRO and vendor activities while contributing to study start-up and conduct activities, including site-specific ICF review, essential document review, and progress tracking • Conduct site initiation and co-monitoring visits • Train and support site personnel on sponsor and regulatory requirements • Lead or participate in investigator meetings • Prepare or review detailed visit reports and documentation • Serve as sponsor liaison for assigned research institutions from study start-up through close-out • Verify accuracy and completeness of clinical data, source documentation, and regulatory files • Ensure compliance with study protocols, SOPs, GCP, GDPR, and local and global regulations • Identify, investigate, and resolve discrepancies in study documentation • Implement corrective and preventive actions to reduce recurrence • Review and maintain Trial Master File documentation for audit readiness • Ensure alignment with Good Documentation Practices and regulatory expectations, including FDA, ISO14155, and EU-MDR • Partner with cross-functional teams to support site activation, enrollment progress, and data cleaning according to study timelines

🎯 Requirements

• Bachelor’s degree in a scientific or health-related field • 5+ years of clinical site management experience, including prior field monitoring experience • Strong background in medical devices required; Class III cardiovascular device experience highly preferred • Experience collaborating with CROs, core labs, and external vendors • Prior involvement in site- and sponsor-level regulatory agency audits (FDA or BIMO experience a plus) • Strong written and verbal communication skills, with the ability to present clearly to varied audiences • Experience in a Cardiac Cath Lab setting highly preferred • Demonstrated problem-solving, critical thinking, and organizational skills, with keen attention to detail • Proficiency with MS Office Suite, Adobe, and EDC platforms (e.g., Medidata RAVE, Viedoc); working knowledge of CTMS and eTMF systems • Thorough knowledge of GCP, FDA, ISO14155, and other relevant regulatory frameworks • Clinical research certification (ACRP or SOCRA, CRA/Coordinator certification) preferred • Ability to travel up to 50% during activation and early enrollment; ~30% otherwise across Europe • Fluent in spoken and written English required • Preference given to qualified candidates with fluency in French and German • Other EU languages (e.g. Dutch, Danish) a plus

🏖️ Benefits

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies • Collaborative and dynamic work environment with a culture of innovation and excellence • Competitive compensation package, including salary and performance-based bonus • Career development opportunities • Chance to be part of a growing company that values its employees