Senior Clinical Project Manager

Minnetonka, 130 Cheshire Lane, Minnetonka, Minnesota, United States of America •

Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America

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.

POSITION SUMMARY:

This position will be responsible for managing and meeting the objectives of Atri Cure clinical study projects(s). The Senior Clinical Project Manager has a proven competency in clinical research with experience in all aspects of clinical trial execution from start up to data reporting.

This position is responsible for leading the execution of Ari Cure’s clinical study project(s) acting as the primary liaison with clinical study site(s), outsource partners and internally interfacing across all functional disciplines within the company.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Manages all aspects of program activities including budget and project planning.
• Oversee the planning and execution of clinical study(s) to ensure that deliverables are conducted with integrity, completed to achieve scheduled milestones and goals and within budget.
• Coordinates and consults with the cross functional project team, project stakeholders and the clinical study team providing direction to internal and external study team members as required.
• Monitors study progress from internal study team members and outsource partners for accuracy and trending.
• Presents study plans, provides ongoing updates and progress reports to internal and external stakeholders.
• Assists in ensuring trial is “audit ready” at all times
• Evaluates integrity and quality of clinical data in preparation for study summary reports for presentations, publications, and submissions.
• Contributes to the development and implementation of site corrective actions to address any site compliance issues.
• Oversees activities delegated by VP, Clinical Affairs and/or VP, Regulatory Affairs specific to the company’s clinical/regulatory submissions.
• Leadership of internal clinical research teams and CROs to deliver on business objectives.
  
  Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices.
• Supports all company initiatives as identified and in support of the quality system and other regulatory requirements.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Advanced written and verbal communication skills.
• Expertise with GCP’s and regulatory compliance guidelines for clinical trials (E.G., applicable ISO Standards, FDA).
• Regular and predictable work performance
• Ability to travel occasionally (no more than 20%)
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree required, in the Sciences preferred, or demonstrated equivalent combination of education, training and experience.
• Minimum 5 years’ project management…