Sr Clinical Quality Manager

Clinical St. Paul, Minnesota


Description

Job Summary

As a member of the Clinical Leadership Team, the Sr. Clinical Quality Manager will lead all clinical quality efforts to ensure compliance with CSI procedures and global regulations for clinical studies and daily operations. The Sr. Clinical Quality Manager is responsible for independently developing and maintaining contemporary clinical quality programs, plans and procedures to include compliance reviews, risk assessments, ongoing monitoring and education to the Clinical Affairs function. Management responsibilities include people leadership of members of the CRA team and/or Clinical Operations team and clinical quality consultation on clinical strategies, plans and protocols. Leveraging their extensive experience and knowledge of global regulations, this role works with all members of Clinical Affairs to drive quality awareness and audit readiness. This position collaborates with CSI’s Quality and Regulatory teams, and other related areas to develop cross-functional processes to ensure a compliant and connected quality system. The candidate must possess strategic thinking, examples of project execution, strong communication, influence and leadership skills and consistently model the CSI core values of accountability, integrity, excellence, courage, velocity and community.

 

Essential Duties and Responsibilities
Works under the direction of the Sr. Director of Clinical Affairs to:

  • Develop and maintain a robust clinical quality program to include new and relevant procedures, processes, compliance reviews, risk assessments, monitoring and education/training
  • In partnership with the Director of Global Clinical Evidence and Strategy and CSI’s Quality and Regulatory teams, create strategies and implement plans to meet evolving global requirements and standards
  • Clinical Affairs lead contact for CSI Quarterly Quality Management meetings
  • Partner with Clinical Franchise Leads to determine impact of new and existing regulations on pre- and/or post-market clinical data requirements.
  • Identify key areas of regulatory risk and suggest mitigations or resolutions
  • Provide oversight of the clinical CAPA activity
  • Own the clinical audit program including all education, preparation, reviews and activities
  • Lead the coordination and management of regulatory agency inspections for Clinical Affairs
  • Leverage metrics to monitor and report on department compliance/risk
  • Advise on vendor management and outsourcing strategies to ensure compliance and reduce risk to the organization through periodic audits, risk mitigations and action plans
  • Manage direct reports through coaching, mentoring and training; provide ongoing feedback and annual performance reviews. Develop robust individual performance objectives in partnership with functional owners.
  • Provide support for clinical personnel which may require facilitating successful interactions with key functional groups (e.g., Clinical Information Systems, Monitoring, Safety, Core Lab, Clinical Payments)
  • Ensure departmental compliance as well as appropriate departmental resources are available to effectively maintain the quality system (people, facilities, tools, and training)

 Knowledge, Skills and Abilities Required for Successful Job Performance:

  • BA/BS degree in healthcare or scientific-related field and a minimum of 15 years combined experience in medical device clinical research, clinical quality or quality
  • Minimum of 5 years of experience with demonstrated leadership ability (e.g., project and/or direct people supervision, clinical study management, team leadership)
  • Extensive experience with FDA, ICH E6, EUMDR, ISO13484, Ord 36, GDPR and global regulations relevant to medical device clinical efforts
  • Demonstrated ability to:
  • Successfully navigate and influence in a matrixed environment; lead and collaborate across multiple roles and functions to reach shared goals
  • Effectively communicate, collaborate and influence across all levels of the organization from individual to executive
  • Create strategic work plans for self and team and advise on shifting priorities and competing demands
  • Maintain a connected framework of SOPs and clinical quality program to address evolving global requirements
  • Lead people and differentiate performance, develop individuals and effectively manage performance issues
  • Independently solve problems of significant complexity
  • Educate and lead groups through changing processes and procedures
  • Experience with project management and fluency with related tools (e.g., MS Project)
  • Proficient knowledge of medical terminology
  • Knowledge of coronary and/or peripheral experience desired

Specifications/Other

  • Working Conditions
    • Works in office environment
    • Physical abilities (must be able to lift 20 lbs)
    • Mental abilities (view computer screen 8 hours per day)
  • We are a fast-growing global company with opportunities for growth
  • Up to 15% domestic and international travel

 

CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.