Senior Global Clinical Project Manager

Sr. Global Clinical Project Manager

Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world's first biomimetic TAVR valve, DurAVR THV. This cutting-edge valve, incorporating our proprietary ADAPT anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.

The Sr. Global Clinical Project Manager plays a pivotal role in bringing a groundbreaking transcatheter heart valve (THV) and delivery system to patients worldwide. This position leads the operational execution of a global pivotal clinical trial, driving it from initiation through completion with precision, integrity, and urgency. Partnering with cross-functional leaders, global sites, CROs, and specialized vendors, this role ensures every milestone is met, every risk is mitigated, and every detail aligns with the highest scientific, regulatory, and ethical standardsultimately advancing a device designed to redefine outcomes in structural heart disease.

This is more than a clinical project management roleit's an opportunity to lead a pivotal global trial that could transform the standard of care in transcatheter heart valve therapy. You will be at the helm of bringing a first-of-its-kind THV and delivery system to market, collaborating with world-class clinicians, engineers, and innovators. Your work will directly impact patient lives, enabling a device designed not just to treat, but to restore healthy heart function for a broader and more active patient population.

At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Key Responsibilities :

• Lead Global Trial Operations : Oversee all project-level activities for a pivotal, multi-country clinical study, managing timelines, budgets, resources, and vendor deliverables to ensure on-time, on-budget execution.
• Ensure Regulatory & Quality Excellence : Develop, implement, and maintain systems and procedures that comply with company SOPs, GCP / ICH guidelines, and FDA and international regulatory requirements.
• Vendor & Partner Collaboration : Manage relationships and performance of CROs, Core Labs, Data Monitoring Boards (DMBs), Clinical Event Committees (CECs), and other strategic partners to ensure seamless study execution.
• Drive Study Team Alignment : Lead the global study team, fostering clear communication and operational consistency across all sites to meet organizational objectives.
• Proactive Progress Tracking : Design, update, and interpret study reporting tools to monitor trial performance, compliance metrics, and risk mitigation strategies.
• Device Management Oversight : Coordinate device disposition and tracking in close collaboration with field personnel, operations, and clinical sites to maintain full accountability.
• Maintain Documentation Integrity : Ensure timely and accurate filing of all project-level documentation in the Trial Master File (TMF) in accordance with regulatory and company requirements.
• Strategic Study Planning : Work cross-functionally to create and maintain study plansincluding safety, data management, and monitoringensuring compliance throughout the trial lifecycle.
• Leadership & Mentorship : Provide oversight, guidance, and development support to direct reports, as applicable.

Skills, Knowledge, Experience, Qualifications :

What We Offer :

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Note : We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and / or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision : to be a place of belonging for all humans by promoting diversity, multiculturism, and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.