EDWARDS LIFESCIENCES, Senior Manager, Clinical Research Monitoring

Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The Senior Manager, Clinical Research Monitoring, will manage a team of clinical researching monitoring professionals and clinical related activities. The role will require up to 35% of travel within the United States& considering candidates from all U.S. territories.


Key Responsibilities:
• 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