Edwards Lifesciences Manager, Clinical Trial Management (Irvine, CA Based) – Transcatheter Mitral and Tricuspid Therapies in Irvine, California
Manager, Clinical Trial Management – (Irvine, CA) Transcatheter Mitral and Tricuspid Therapies (TMTT)
This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards’ Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives around the world.
Edwards Lifesciences Transcatheter Mitral and Tricuspid division has a unique opportunity for a Manager, Clinical Trial Management (Internally titled as Manager, Clinical Project Management) to join our growing team, to be accountable for key study deliverables within timelines and budget. The Manager will conduct and report studies in accordance with all applicable regulatory requirements, will be adaptable and a problem-solver with the ability to work within cross-functional teams and to evaluate and manage research studies.
This role is located in and based out of Irvine, California. We offer a Comprehensive Relocation Package.
Essential Job Functions and Key Responsibilities:
Clinical Study Execution, including Clinical Research Monitoring and Clinical Site Management
Responsible for study start-up and study conduct activities including managing essential documents
Manage study milestones, including accurate tracking and reporting of study metrics
Execute site monitoring strategies, risk mitigation strategies, trial budgets, and site selection
Generate and review of various site visit reports
Investigate and execute resolutions for discrepancies in study documentation, by applying clinical protocol knowledge and GCP
Managing and communicate the status of study progress and activities
Maintains effective working relationships with affiliate teams, external CRO and co-development partner study teams
Manage study timelines, resources, budget, risk and quality plans
Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Director.
Creates team culture and promotes team spirit
Travel up to 45%
Bachelor’s degree in a life science or related field
Minimum of 10 years of medical device/pharmaceutical/biotech/CRO industry experience with a minimum of 5 years of study management experience managing complex international clinical studies.
This role will have direct reports. Must have strong leadership skills and proven line management experience.
Preferred Qualifications: In addition to meeting minimum requirements, it would be nice to have the following:
Experience working on IDE studies that comply with IDE regulations.
Independent monitoring experience as a CRA managing investigator sites.
Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)
Knowledge of Cardiovascular Physiology and structural heart anatomy is a strong preference
Prior clinical research experience within Medical Devices including PMA, IDE, 510k is a strong preference
Additional Skills and Expectations:
Full understanding of regulatory submissions, reporting, and audits
Prior Medical Device Experience
Full knowledge and understanding of ICH and GCP guidelines
Ability to manage confidential information with discretion
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
#LI-MO1 #LI-MO #MI
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.