Manager, Clinical Trial Management

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 Clinical Trial Manager to join our growing team.  Internally titled as Manager, Clinical Project Management - The Clinical Trial Manager will be accountable for key study deliverables within timelines and budget. The Clinical Trial 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 based in Irvine, California. Responsibilities but not limited to: 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 30-50% travel within the United States #LI-MO1 #MI Required Education / Skills / Experience:  Required: 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 clinical studies. Preferred: 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  Prior Class III Medical Device Experience strongly preferred Additional Skills and Expectations: Full understanding of regulatory submissions, reporting, and audits 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. 016581
Salary Range: NA
Minimum Qualification
11 - 15 years

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