Manager, Clinical Research Monitoring

About the role

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Responsibilities

• 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.
• Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms.
• 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.
• Providing direction and guidance to execute project deliverables in collaboration with project managers.
• Identifying and evaluating clinical process improvement opportunities.
• Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence.
• Participating in the development and validation of case report forms.
• Reviewing 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).

Requirements

• Bachelor's Degree or equivalent in related field with 8 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria.
• Ability to travel up to 75% domestically.

Preferred Qualifications

• Experience working in a medical device or regulated industry
• Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification)
• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• Experience with electronic data capture
• 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 knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
• Extensive understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Strong leadership skills and ability to influence change
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact