Clinical Project Manager

About Atri Cure

Atri Cure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure's cryo

ICE cryo

SPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit  or follow us on Twitter @Atri Cure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

This position will manage clinical research projects, including key activities of landmark, global clinical trials, in a fast‑paced environment with a focus on planning, execution and management of all operational aspects. Interfaces with the VP and Director, Clinical Affairs, and senior managers to provide tactical/operational leadership to members of the clinical study team, including cross‑functional departments which support the clinical development process.

[e.g., Clinical Research Associates (CRAs), Regulatory Affairs, Medical Affairs, Scientific Affairs, Biostatistics, Statistical Programming, Medical Writing, Data Management, Quality Assurance, Safety].

• Lead, execute, and monitor progress and performance of assigned clinical studies and programs globally, in accordance with strategy, project plans, and budget following applicable regulatory and standard operating procedures.
• Oversee the development of and collaborate with the study team on key trial deliverables such as protocols, informed consent documents, case report forms, trial guidelines, annual progress reports, final reports, and sponsor‑required regulatory submissions.
• Drive identification, qualification, and selection of clinical sites and maintain continuous audit‑readiness.
• Lead proactive identification, assessment, and management of clinical study risks and present study progress and known risks to senior leadership.
• Select and manage ongoing relationships with external vendors (CROs, core labs, central IRB, etc.) and oversee contracts and agreements for all aspects of assigned clinical studies.
• Oversee development of Clinical Monitoring Plan(s) and adequate monitoring of clinical study sites; conduct site trial training and investigator meetings, and support investigators and site coordinators to resolve site‑related issues.
• Manage day‑to‑day project activities of CRAs assigned to specific projects, handle escalation of study‑related issues, and establish appropriate mitigation plans.
• Ensure adequate clinical data collection and follow‑up compliance; participate in study data review and interpretation, and oversee clinical report writing.

• Remove roadblocks and manage study teams directly and indirectly to drive clinical studies and projects to on‑time and within‑budget completions.
• Gather information from multiple sources, analyze, integrate, resolve conflicting requirements, and drive the clinical affairs organization through challenges to result in a successful clinical study.
• Work under fast‑paced conditions, make decisions, use good judgment, prioritize duties, and multitask as required.
• Work with others and understand deliverables from cross‑functional teams.

• BS in a science or related technical field, including a minimum of 6 years of related work experience or an equivalent combination of education and work…