Clinical Study Manager, Critical Care

Clinical Study Manager, Critical Care

01 Nov 2022
California, Irvine, 92602 Irvine USA

Clinical Study Manager, Critical Care

For over 50 years, Edwards Lifesciences Critical Care technologies have been helping clinicians make proactive clinical decisions to advance the care of surgical and critical care patients.Through continuing collaboration with our clinicians, ongoing education, and our never-ending quest for innovation, Edwards continues to develop hemodynamic management solutions that enable clinicians to provide better care to patients in the OR, ICU, and ED settings.We are searching for a Clinical Study Manager to join Edward’s Critical Care business unit based near global headquarters in Irvine, California. As a Clinical Study Manager, you recruit and manager clinical evidence projects within Medical Affairs to include Real World Evidence (RWE) or other pragmatic clinical studies and Investigator Initiated Studies (IIS). You are a key member of the Scientific Communication Committee, contributing to internal and external dissemination of relevant clinical evidence. You also lead other market development activities such as Medical Advisory Boards and clinical market development initiatives.Essential Job Functions/Key Responsibilities:Manage external and internal communication related to U.S. based IIS proposals, direct logistical support of approved projects, and facilitate collaboration with cross-functional teams related to data collection opportunities

Manage external and internal communication and logistics for RWE projects. Identify new research opportunities aligned with CC Med Affairs strategic objectives and lead project teams for execution of clinical evidence publications, in collaboration with cross-functional stakeholders

Key contributor to CC Scientific Communication strategy and liaison between Med Affairs Sci Comm team and cross-functional stakeholders including Marketing, Brand, Professional Education and Sales Training teams

Build strong sustainable relationships with key healthcare providers and clinical researchers

Provide input on IIS (investigator-initiated studies) process and execution to KOLs and ensure compliance with local regulations

Plan and direct clinical market development activities and initiatives which included scientific evidence generation and promotion

Minimum Requirements:Bachelor’s degree and 10 years of experience working in clinical trials OR

Master’s degree and 8 years of experience

Local or ability to relocate to Orange County and work onsite at Edward’s global headquarters

Ability to travel up to 40% globally/domestically

Preferred Qualifications: In addition to meeting minimum requirements, it would be nice to have the following:Demonstrated ability to develop KOL relationships and drive alignment of objectives

Expert knowledge and understanding of anesthesia and critical care clinical setting and application of advanced hemodynamic monitoring technologies

Ability to interact professionally and effectively present content at all organizational levels

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.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 15,000 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.

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