Edwards Lifesciences Associate Manager, Clinical Project Management - Transcatheter Mitral & 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. You 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.
As an Associate Manager, Clinical Project Management, you are responsible for clinical trial management of multiple studies and may be subject matter expert for assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials.
Essential Job Functions/Key Responsibilities:
Manage and/or lead a small team including performance management. Develop team members to increase business acumen and functional skills
Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s)
Provide direction, guidance, and oversight of clinical core teams to execute projects and initiatives
Manage project status and appropriate communication both internally and externally
Analyze trial performance to plan and develop corrective actions.
Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in collaboration with management
Oversee the selection of clinical vendors and study sites
Minimum 8 years of experience monitoring clinical trials and with study start up
Extensive understanding of regulatory submissions, reporting, and audits
Extensive knowledge and understanding of international and domestic medical device regulatory guidelines relevant to clinical protocols
Medical device experience
Experience with class III devices, specifically in the structural heart space
Proven project management experience
Expertise with clinical systems such as CTMS (clinical trial management system) and eTMF (electronic Trial Master file)
Experience managing employees and demonstrated informal mentoring and peer leadership skills
Knowledge of financial mechanism that relates to clinical trials
Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Additional Talents and General Expectations:
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical trials to the business
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environmentPrimarily interacts with internal subordinates and other supervisors
Typically interacts with external suppliers, vendors and/or customers
Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
Dedicated to quality client service and pro-active and responsive to client needs
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.