Manager, Clinical Research Monitoring

Edwards Lifesciences is dedicated to generating clinical evidence for their innovative products that transform patients' lives. The Manager of Clinical Research Monitoring will lead a small team, oversee clinical trial conduct, and ensure compliance with protocols and regulatory requirements while mentoring junior employees.

Responsibilities:

• Managing and leading a small team within assigned function including team budget responsibilities and managing outside contractors/vendors. Developing team members to increase business acumen and functional skills
• Providing input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), acting as a Core Team lead, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
• Leading in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Acting as a mentor to new or junior level employees
• Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence
• Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms
• Participating in development and validation of case report forms
• Reviewing and approving monitoring visit reports
• Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees
• Reviewing and completing checklist on informed consent forms (ICF)
• Providing direction and guidance to execute project deliverables in collaboration with project managers
• Identifying and evaluating clinical process improvement opportunities

Requirements:

• Bachelor's Degree in related field with previous field monitoring experience, quality assurance/control and regulatory compliance required or equivalent work experience based on Edwards criteria
• Ability to travel up to 75% domestically and internationally
• 8+ years of related experience in cardiology trials
• Master's Degree in related field
• Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)
• Strong understanding of ISO 14155, FDA, and international regulatory requirements
• Ability to lead and mentor field monitors
• Strong understanding of risk-based monitoring, strategies and tools to ensure compliance and data integrity
• Ability to resolve conflicts and provide clear guidance
• Proficiency in trial management systems (e.g. RAVE, CTMS, Veeva, & monitoring dashboard)
• Proven successful project management leadership skills
• Proven expertise in MS Office Suite, including Word, Excel, and Adobe
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
• Extensive understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment