Clinical Quality Manager

AtriCure, Inc. • Minnetonka, MN

29d

About The Position

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, AtriCure 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 AtriCure policies, procedures and processes for the conduct of clinical studies.

Requirements

• Bachelor's degree with relevant medical, scientific/clinical experience.
• Minimum 5 years of experience working in medical device (preferred), pharma, biotech clinical quality assurance/operations roles.
• Direct experience with health authority inspections such as US FDA BIMO inspections (Sponsors, CROs and/or Clinical Investigator sites), BSI inspections etc.
• Experience preparing investigational sites for inspection by regulatory agencies.
• Experience in auditing clinical vendors, CROs and internal clinical programs.
• Exceptional written and verbal communication and influencing skills, with the ability to communicate effectively at all levels of the organization including with external regulatory agencies.
• Strong people leadership and talent development skills.
• Demonstrated strategic thinking and leadership skills.
• Independently motivated, detail oriented, strong analytical and problem-solving skills, with a focus on risk management and continuous improvement.
• In depth knowledge of guidelines and FDA/ISO regulations for pre- and post-market clinical trials.
• Previous experience of CTMS, eTMF and EDC systems.
• Skilled at working effectively in a collaborative team environment.
• Proficient in Microsoft Office skills, including Excel, Word, and Power Point.
• Ability to exercise judgment and determine appropriate action.
• Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment, and manage deadlines.
• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
• 25% travel possibility
• Ability to pass pre-employment drug screen and background check

Nice To Haves

• Master's degree with 3 years relevant medical, scientific/clinical experience in a GCP practice area; Clinical Quality Assurance or similar role preferred.
• Global Clinical Quality experience (e.g. APAC, EU, UK, etc.)
• Expert CAPA knowledge and experience
• Previous experience working as a Clinical Quality Manager within a cardiology therapeutic area
• Direct management of clinical quality personnel (Quality specialists), remote and onsite, providing work direction, guidance and mentoring

Responsibilities

• Maintain and monitor AtriCure 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 AtriCure 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, AtriCure 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 Organization as needed, including AtriCure Registry Studies.
• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

Benefits

• Medical & Dental beginning day 1 of employment
• 401K plus match
• 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
• Volunteer Time off
• Pet Insurance
• on-site fitness center and cafeteria

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 1,001-5,000 employees