Edwards Lifesciences Critical Care division has a unique opportunity for a Manager of Clinical Affairs 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. The candidate will be adaptable and a problem-solver with the ability to work within cross-functional teams and to evaluate and manage research studies.
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.
Bachelor’s degree in a life science or related field with a 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.
Experience of project managing operational aspects of a clinical study including timelines, budgets and resource plans.
Strict attention to detail
Minimum of 5 years of independent monitoring experience as a CRA managing investigator sites.
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
Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)
Knowledge of Cardiovascular Physiology and/or Hemodynamic Monitoring
Prior clinical research experience within Medical Devices including PMA, IDE, 510k
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.
Internal Number: 012778
About Edwards Lifesciences
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
BACK TO TOP
International Association of Healthcare Central Service Materiel Management (IAHCSMM)