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Senior Manager, Clinical Affairs – Critical Care

Edwards Lifesciences LLC


Location:
Irvine, California 92614
Date:
06/28/2017
2017-06-282017-07-28
Job Code:
011329
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
  • Medical Affairs
Edwards Lifesciences LLC
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Job Details

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.

Requirements

Required Education / Skills / Experience: 

Required:
  • 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 
Preferred:
  • Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)

Additional Skills:
  • 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.

 

About Edwards

Edwards has been advancing the care of the acutely ill for more than 40 years. Starting with the development of Swan-Ganz advanced hemodynamic monitoring devices for measuring cardiovascular performance in high-risk surgical and critically ill patients, Edwards continues to evolve to less-invasive and noninvasive devices to provide valuable hemodynamic insight for an expanded patient population. Edwards has continued to advance hemodynamic monitoring platforms to enable proactive clinical decisions for surgical, anesthesia and critical care clinicians. Edwards is focused on helping clinicians enhance knowledge and standardize practice to improve the quality and efficiency of care. Edwards provides evidence-based programs such as Enhanced Surgical Recovery Program that support the implementation and compliance to protocolized care pathways in the OR and ICU.


Our vascular therapies products, including genuine Fogarty catheters, continue this high standard. Developed and refined in close collaboration with surgeons and interventionalists for over 50 years, Fogarty catheters have been used in millions of procedures worldwide.


Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save 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.