Edwards Lifesciences Manager, Clinical Systems - Irvine, CA - Transcatheter Mitral and Tricuspid Therapies (TMTT) in Irvine, California
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.
The Clinical Systems Manager will manage a team and lead the execution of the global rollout for process alignment and optimization with regards to computerized systems and reporting tools used within BU Clinical Affairs. Partner closely with clinical business users and with Clinical IT to drive clinical system implementations and enhancements.
Essential Job Functions/Key Responsibilities:
Manage and oversee the work of a team and may indirectly manage cross functional or matrix teams as appropriate. Manage, mentor and provide guidance to lower level clinical systems staff and contractors.
Lead system related process activities to support rollout and optimization of clinical systems and reporting tools. This includes partnering closely with clinical business users and Clinical IT to help develop and document system requirements, assist with system validations and work cross functionally with various stakeholders on system implementations.
Assess project performance to monitor the progress of the projects, identify and quantify variances, perform required corrective actions and communicate to all stakeholders.
Develop a robust talent development plan in alignment with functional growth strategies of the department, and performance management of team.
Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams.
Partner closely with clinical business users and Clinical IT on the specification, documentation, validation, and implementation of clinical systems and payment optimization projects. Ensure documentation and validation practices are consistent with company policies.
Develop and facilitate clinical systems training in collaboration with clinical business users and Clinical IT.
Act as the Clinical point of contact and Subject Matter Expert of clinical systems to business users globally.
Assess knowledge and/or quality gaps of clinical staff and determine appropriate training plans and/or needs in collaboration with trial management.
Review, develop, and manage workflow and work process standards to ensure that clinical systems activities are in compliance with the regulatory and company requirements. Ensure work instructions are updated.
Bachelor’s Degree with 10 years of related experience required.
Experience leading the implementation of systems required.
Experience with people management
Experience in clinical research field within medical device industry
Experience working in a regulated industry preferred.
Proven successful project management leadership skills
Demonstrated competency managing projects from inception to completion
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Demonstrated problem-solving and critical thinking skills, attention to detail, and performance of duties
Ability to interact professionally with all organizational levels, across functional areas and across global regions
Ability to adapt to new technologies and rapidly changing environment
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels within the organization
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.