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Director, Clinical Field Operations – Transcatheter Heart Valv
IRVINE CA 92604
Category: Health Care Industry
  • Your pay will be discussed at your interview

Job code: lhw-e0-85068085

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Edwards Lifesciences

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Summary

  Job posted:   Sun Feb 25, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
Director, Clinical Field Operations – Transcatheter Heart Valv
**Objectives:**


The Director of Clinical Field Operations in partnership with the Senior Director of Clinical Operations will develop an efficient, strategic, field-based workforce to support THV clinical research global programs. Special attention will be given to outlining collaborative roles and responsibilities, tracking staff utilization and performance metrics, and ensuring sufficient resources are available to deliver study milestones on-time. Field activities include on-site, remote, and risk-based monitoring of patient data, in-hospital clinical procedure support, and site management support of project/study goals. This role oversees the global teams of Clinical Field Monitoring and Clinical Field Specialists and interfaces directly with the Directors of Project Management, Data Management, and Safety. Additionally, the Director of Clinical Field Operations will work cross-functionally to develop processes towards continuous process improvement.


This role will interact with key internal stakeholders, which may include US Clinical Affairs functional partners, HE&R, Scientific Communication, and the Clinical Program Management Office; and Global functional groups such as Regulatory Affairs, Data Management and Biostatistics, and Legal. This role will provide support to Edwards' staff and others in liaising with internal and external key stakeholders such as key opinion leaders, investigators, authors, partners, and affiliates on publication activities related to assigned devices/programs. The Director of Field Operations will be responsible for oversight of study documents and/or business systems utilized by field operations.


**Accountabilities:**


+ Builds high-performing teams.

+ Identifies training needs and implements appropriate training for field operations staff.

+ Analyzes staffing needs working with Field Managers to gather necessary data to support coverage of current and upcoming studies.

+ Identifies process improvements and works cross-functionally to develop efficiencies, standardization, and quality deliverables.

+ Creates templates in alignment with corporate SOPs.

+ Ensures field staff follow all elements of ICH/GCP.

+ Provides metrics to upper management to support field operations.

+ Works with vendors to support field operations.


#LI-JB1


Qualifications:


**Qualifications:**


**Required:**


+ Bachelor's degree or equivalent is required (preferably in a scientific discipline); a Master's degree or PhD is preferred.

+ Requires a minimum of 12 years of clinical research experience. Experience in related field or technology, with a minimum of seven years managerial level experience, a track record of personal career development, and clinical trial management experience is required, preferably in medical devices. Experience in critical care, cardiovascular surgery and/or interventional cardiology a plus.

+ Documented current continuing education in clinical research monitoring or experience in Clinical Research Project management experience is a must.

+ Working knowledge of pharmaceutical or medical device development and product life-cycle management.

+ Strong knowledge of GCP/ICH E6 and federal regulations.

+ Ability to understand and interpret medical/scientific data.

+ Experience and knowledge of clinical trial reports, data presentation, and interpretation.

+ Experience in Clinical Affairs/Medical Affairs/R&D functions.

+ Strong interpersonal skills are required. Must have demonstrated skills in the following areas: leadership, coaching and counseling, and strategic clinical trial planning.

+ Excellent written and oral communication skills.

+ Effectively work with and lead cross-functional teams.

+ Experience with resourcing and financial management.

+ Experience with resource allocation and vendor management.

+ Project management skills.

+ Experience with managing budgets.


**Preferred:**


+ Advanced degree, preferably in a scientific discipline, or sufficient applicable experience.

+ Experience with site management, preferably as a study coordinator or cath lab coordinator.


**Travel requirements:**


+ Ability to travel (up to 40%) to work with field staff and physicians/staff on-site, as well as attending internal and professional meetings and conferences. International travel will be required.


About Edwards

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.


Title: Director, Clinical Field Operations - Transcatheter Heart Valve
Location: USA-USA-California - Irvine
Job Number: 013173

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