Job description

Transcatheter Mitral and Tricuspid Therapies (TMTT) is 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 Senior Manager, Clinical Trial Management / Clinical Project Management , you will be 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. This is a hybrid position located at our Irvine, CA, headquarters, some days are office-based, and some days can be worked from home.

Key Responsibilities:

• Manage and oversee the work of team and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department
• Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for larger or more complex clinical trials through experienced team members 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 larger or more complex projects and initiatives. Determine clinical trial resources and set priorities for projects
• Manage project status and appropriate communication both internally and externally. May present trial information at executive and/or industry conferences
• Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in alignment with management
• Oversee the selection of clinical vendors and study sites
• Other incidental duties

Minimum Education and Experience:
Bachelor's Degree, required

Minimum of 10 years of medical device or sponsor industry work experience in clinical trial management, required

Ability to travel up to 30% for meetings/conferences, required

Demonstrated track record in people management, required

Covid vaccination requirement

Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:

Experience with structural heart therapeutic area, is a plus

Experience with large scale early feasibility/pivotal trials, study start-up to closure, is a plus

Class III Medical Devices including PMA, IDE, 510k is a strong preference

Additional 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 ability to drive achievement of objectives
• Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols while addressing issues with impact beyond own team based on knowledge of related disciplines
• Expert understanding of regulatory submissions, reporting, and audits
• Knowledge of financial mechanism that relates to clinical trials
• Demonstrated ability 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
• Ability to develop and integrate metrics into the projects and operations that clearly 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 levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
• Participate and present at meetings with internal and external representatives
• Resolve operational and scheduling issues
• 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.
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels within the organization
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $123,000 to $174,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

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.

COVID Vaccination Requirement

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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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