Edwards Lifesciences Senior Manager, Clinical Research (Remote, US) Advanced Technology in Kansas
An exciting opportunity with the Advanced Technologies team currently involved in new cutting edge products and processes. In this innovative team you provide leadership and clinical expertise in support of new product development and/or marketed products. This position leverages applied research, design and development experience in new medical device and product development.
Manage professionals and oversee the work of multiple projects and/or initiatives and may have financial budget responsibilities.
Develop a robust talent development plan in alignment with functional growth strategies of the department.
Identify risk, develop and lead in the implementation of broad and more complex projects, initiatives and/or strategies which may include negotiations with internal and external parties. Develop mitigation strategies, alternative solutions, resolve issues, etc. in collaboration with cross functional and/or matrix teams
Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables including but not limited to:
Oversee the relationship management of physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals, research institutions and/or vendors
Ensure compliance to applicable regulatory requirements including safety reporting and device related complications through appropriate oversight
Oversee clinical studies/registries from initiation to completion, while ensuring study compliance and data completeness
Serve as a point of escalation for complex project issues (e.g., sponsor site interaction for IRBs, contract, and training)
Oversee the Clinical Affairs Trial Management Team during clinical trial cases with physicians, hospital staff and coordinators
Oversee the accuracy/effectiveness of device accountability
Ensure enrollment cadence aligns with program projections and milestones
Present trial data at Quarterly Data Reviews; CEC; DSMB; and PI meetings
Bachelor's Degree with 12 years of previously related experience including medical device, pharmaceutical, biotech and/or CRO industry experience inclusive of study management experience managing complex clinical studies OR
Master’s degree with 10 years of previous related experience as listed above
Demonstrated ability to direct teams and provide coaching and feedback including responsibility for all employee actions including hire/fire authority and partnering with human resources on all aspects of employee relations
Ability to travel up to 20% for conferences and site visits
Medical device project management and trial management experience
Clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas
Prior clinical research experience with class III medical devices including PMA, IDE, 510(k)
Understanding of international and domestic medical device regulations and guidance
Full understanding of regulatory submissions, reporting and audits
PMP certification and Microsoft Project expertise
Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems
Local or ability to relocate to Orange County and work onsite at Edward’s global headquarters. Full relocation package provided.
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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, 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.