Senior Director Clinical Operations and Clinical Quality

Why work for CVRx?

CVRx pioneers' unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.

A day in the life:

The Senior Director of Clinical Operations and Clinical Quality is responsible for leading the development, implementation, and execution of clinical research studies consistent with the CVRx clinical strategy, and applicable regulations and policies.  The Senior Director of Clinical Operations and Clinical Quality is responsible for the hiring, management, and development of the clinical operations team as well as oversight of operations budget and all ongoing clinical programs. This role also provides strategic planning for continuous improvement efforts, reporting/escalation of quality issues, conducting risk mitigation for clinical trial activities, and ensuring a compliant culture of quality through effective leadership and strong cross functional collaboration.

People Management

• Responsible for management, leadership and development to all clinical operations staff.
• Leads recruitment and hiring of clinical staff.
• Responsible for team culture, talent development and organizational structure for clinical operations.
• Responsible for development of a training program for clinical operations employees to assure appropriate regulatory, SOP, GCP and disease state training during onboarding and on an ongoing basis.

Trial and Data Management

• Leads the development of Investigational Plans in partnership with Clinical Science.
• Leads development of study documents, schedules and site communication and training materials.
• Evaluates and implements appropriate tools and infrastructure (e.g. EDC, CTMS, ePRO, study reports) to assure efficiencies for clinical operations team and clinical sites for conduct of clinical studies.
• Leads data management function to assure adequate study reports during study conduct and creation of reports for regulatory agencies summarizing study results.
• Leads project management of all clinical trials to assure effective study execution in alignment with department and company goals/objectives.
• Participation in the creation of study operations budget and resource plan, and responsibility for compliance to budget and reforecasting efforts.
• Leads the development of study internal and external communication tools to create visibility of clinical study progress.
• Oversight of all site qualification and selection activities in partnership with Clinical Science.
• Assure strong communication and relationships with clinical site research staff and investigators.
• Interfaces with regulatory agencies (in conjunction with Regulatory personnel) regarding requirements and results of the study.
• Oversees the selection and management of contract research organizations and other outside vendors (budgets, timelines, and compliance).
• Oversees all event adjudication and safety committees.
• Participates in publication committee activities.
• Partnership with Clinical Science in the development of abstracts, manuscripts and presentations of CVRx clinical data.

Quality

• Partnership with Regulatory and Quality organization to assure compliance with safety and post market surveillance requirements.
• Serves as primary contact for clinical department internal and external audits.
• Ensures compliance with SOPs and regulations for all ongoing studies and assures appropriate application based upon study geography (e.g. US, EU) and study type (e.g. IDE, post-market).
• Responsible for the writing and /or maintaining of departmental SOPs, work instructions.

Requirements

What we expect from you:

• Bachelor’s degree in engineering, biological sciences or related medical/scientific field.
• 10 years medical device clinical trial operations expertise (e.g., site management, data management, monitoring, regulatory compliance).
• 5 years' experience in direct people management with a track record of building innovative and accountable team culture.
• Experience with trial conduct in the U.S and Europe.
• Experience with conduct of IDE and post-market trials.
• Experience with GCP and regulatory