Clinical Quality Manager

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:

The Clinical Quality Manager will support the Clinical Affairs Organization in ensuring the quality and compliance of studies conducted within the clinical portfolio. This role will be responsible for leading and proactively driving clinical quality behaviors, accountability, and cross-functional collaboration (e.g. Clinical Programs, Scientific Affairs, Atri Cure Quality, Regulatory Affairs, Medical Directors, Study Teams, Investigational Trial Sites, and external vendors) with respect to clinical quality assurance activities.

The Clinical Quality Manager will also drive continuous improvement in adherence to agency regulations and standards, GCP, global industry guidelines, and Atri Cure policies, procedures and processes for the conduct of clinical studies. ESSENTIAL FUNCTIONS OF THE POSITION:
Maintain and monitor Atri Cure clinical processes and procedures for compliance with applicable regulations and industry best practices, driving clinical process improvement projects and initiatives for development, enhancement and implementation of controlled documents (e.g. Standard Operating Procedures (SOPs), Work Instructions (WI) and Templates). Lead implementation of Quality processes including audit and inspection readiness activities to ensure clinical studies are conducted in compliance with relevant Atri Cure policies, procedures, regional and local regulatory requirements, and global guidelines and standards.

Support and/or represents the company in clinical audits, coordinating responses with Regulatory Affairs, Atri Cure Quality, Scientific Affairs, legal, and vendors as applicable. Identifies non-conformance with requirements, providing suitable recommendations and facilitating ongoing quality improvements using optimal methodologies while maintaining compliance with applicable study protocols, and global regulatory requirements as applicable. Lead and contribute to the development and maintenance of Clinical Quality metrics for input into process improvement initiatives and/or presentation to study management and leadership teams.

Lead the development and delivery of clinical quality compliance related training to internal functional groups, providing guidance and ensuring study teams are following targeted SOPs/WIs during a study. Assist in development of GCP audit strategies across clinical programs and/or studies. Plans, develops and manages audits of clinical vendors, clinical sites, and/or internal clinical processes, and manages pre/post inspection follow-up activities (e.g. reports, corrective actions) as applicable.

Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulations, including quality control checks of the eTMF to ensure it is inspection ready. Assure appropriate oversight of Clinical Software Validation and Supplier/Vendor Qualification/Management and Approved Supplier Lists in accordance with SOPs as applicable. Leads and/or supports audits, risk assessments and inspections of clinical study vendors.

Work with vendors and support personnel in eliminating issues via root cause analysis techniques to continuously review and improve existing processes. Leads, develops and/or implements inspection readiness programs (e.g. BIMO) and associated activities working closely with cross-functional team members to drive audit/inspection readiness activities and clinical responses, driving process improvements as needed. Responsible for the development and operational implementation of quality assurance initiatives, process improvements, and sound quality principles and practices.

Leads and/or supports harmonization of processes and procedures across the Clinical, Regulatory, Scientific and Medical Affairs…