Senior Clinical Research Associate – EU, Medical Devices

3 days ago

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Anteris Technologies

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Anteris Technologies is a structural heart company focused on developing innovative solutions to the biggest challenges facing aortic stenosis patients and their physicians.

51 - 200 employees

💰 Post-IPO Equity on 2023-02

📋 Description

• Oversee CRO and vendor activities, while also directly contributing to study start-up and conduct activities (e.g., site specific ICF review, essential document review, 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, providing guidance and support to research teams from study start up through close out. • Verify accuracy and completeness of clinical data, source documentation, and regulatory files, ensuring compliance with study protocols, SOPs, GCP (Good Clinical Practice), GDPR, 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 (TMF) documentation for audit readiness; ensure alignment with Good Documentation Practices and regulatory expectations (e.g., FDA, ISO14155, EU-MDR). • Partner with cross-functional teams to support site activation, enrollment progress, and data cleaning in alignment with 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 and a chance to be part of a growing company that values its employees.