Edwards Lifesciences Associate Manager, Clinical Trial Management TMTT in Irvine, California
Associate Manager, Clinical Trial Management – Transcatheter Mitral and Tricuspid Therapies (TMTT)
Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding opportunity to join an early-stage medical device team boldly designing transcatheter mitral and tricuspid therapies from the ground up! The Transcatheter Mitral and Tricuspid Therapies (TMTT) division are passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast-paced, dynamic team - and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization.
As the Associate Manager, Clinical Trial Management, you will be responsible for clinical trial management of multiple studies. You may be subject matter expert for assigned clinical studies, including the planning, implementation, oversight, project management, and completion of clinical trials.
• Manage and or lead a small team, including performance management. Develop team members to increase business awareness 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 according 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
• Other incidental duties
Bachelor's Degree with eight years of previous related experience required
Master's Degree a plus
• Experience working in a large Medical Device company Preferred
• Ability to manage employees and demonstrated informal mentoring and or peer leadership skills
• Proven successful project management skills
• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
• 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 the ability to drive achievement of objectives
• Extensive knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Extensive experience of regulatory submissions, reporting, and audits
• Knowledge of financial mechanism that relates to clinical trials
• Demonstrated skill sets to manage the 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.
• Ability to develop and integrate metrics into the projects and operations that demonstrate the value of clinical trials to the business
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate management levels in the organization
• Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment
• Primarily interacts with internal subordinates and other supervisors
• Typically interacts with external suppliers, vendors and or customers
• Share information and provides essential 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 to prevent injuries to themselves and others, as well as to protect the environment and to avoid 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 13,000 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.