Senior Manager, Clinical Research Monitoring

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 undertreated. 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. As the Senior Manager, Clinical Research Monitoring on the Pulmonic team, you will manage a team of clinical research monitoring professionals and be responsible for managing the strategic direction of field monitoring activities for trials.

The ideal candidate will reside in Midwest/ Northeast region.

You will make an impact by...
• Manage and oversee the work of assigned team within own function and may indirectly manage cross functional or matrix teams as appropriate. Responsible for team budget and outside contractors/vendors. Develop a robust talent development plan in alignment with functional growth strategies of the department
• Lead on the strategic direction of field monitoring of studies and data collection for clinical trials (e.g., increased volume, upstream clinical projects) with increased volume and complexity (e.g., KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
• Provide guidance to team for clinical trial conduct improvements including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence
• Lead 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 Act as a mentor to new or other employees across the company
• Lead team members to take appropriate actions on complex trial monitoring issues (e.g., CAPA) and review escalated monitoring visit reports
• Participate and contribute to the development of clinical protocols, and informed consent forms, and case report forms
• Resolve complex trial/study data and regulatory documentation
• Provide direction and guidance to execute project deliverables in collaboration with project managers
• Initiate and lead the implementation on clinical process improvement opportunities
• Other incidental duties

What you'll need (Required):

• Bachelor's Degree in related field

• 10 years of medical device/sponsor/CRO industry work experience in field clinical research monitoring, quality assurance/control & regulatory compliance, required OR 8 years of medical device/sponsor/CRO industry work experience in field clinical research monitoring, quality assurance/control & regulatory compliance experience and a Masters Degree in related field

• Minimum of 1-2 years of direct people management experience, including a remote workforce

• Ability to travel nationwide up to 50% for monitoring visits/meetings/conferences

• Covid vaccination

What else we look for (Preferred):

• Experience with Risk-Based Monitoring

• Experience with structural heart therapeutic area

• Proven expertise in MS Office Suite, including Word, Excel, and Adobe
• Experience with electronic data capture preferred
• 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
• Expert understanding of clinical studies procedures while addressing issues with impact beyond own team based on knowledge of relate