Edwards Lifesciences Critical Care division has a unique opportunity for a Senior Manager of Clinical Affairs to be responsible and accountable for ensuring key study deliverables within timelines and budget. The candidate will be adaptable and a problem-solver with the ability to work within cross-functional teams and to critically evaluate and manage timelines and key deliverables.
Responsibilities but not limited to:
Provides direction and leadership to one or more clinical operations teams
Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
Creates team culture and promotes team spirit.
Develops and maintains effective working relationships with affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
Contributes to the development and management of the 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 Senior Director.
Develops and manages clinical study budgets.
Establishes study milestones and ensures accurate tracking and reporting of study metrics.
Required Education / Skills / Experience:
Bachelor’s degree in a life science or related field with a minimum of 12 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 development of timelines, budgets and resource plans.
Minimum of 5 years of independent monitoring experience as a CRA managing investigator sites.
Must have previous managerial experience of clinical projects and people
Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)
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.
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, Californi...a, 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.