Manager, Clinical Operations (Irvine, US) – Transcatheter Heart Valve (THV) @ Edwards Lifesciences - Irvine, CA

“Helping patients is our life’s work, and your contributions directly impact our ability to transform patient care around the world.” – Michael A. Mussallem, Chairman and CEO

This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology. The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.

As the Clinical Operations Manager for our THV Core Labs team, you will be responsible for setting up sites with adequate and appropriate training resources, site communications, and data security to provide a platform for study success while also managing a team of clinical operations professionals.

Responsibilities include, but not limited to:
Manage and oversee the work of a clinical operations team and contractors/vendors, as appropriate. Develop team members to increase business acumen and functional skills. Collect performance feedback of assigned staff from cross-functional stakeholders. Assign and prioritize work-related assignments to direct reports.
Plan core labs start-up activities (e.g., contracts, scope of work, case report form development) with accountability for successful completion within scope of project deliverables.
Identify and evaluate alignment opportunities to standardize processes across the organization and lead the implementation of course correction.
Provide strategic direction on field and remote monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial documentation is within parameters of study protocol, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
Analyze clinical output of highly complex studies and provide high level summary with supporting details of study trial status (e.g., Core Lab image perspective) with significant complexity to stakeholders and clinical management.
Develop materials in collaboration with Core Labs and lead the execution of site training (e.g., image acquisition protocols) for clinical stakeholders.

Minimum Requirements:
Bachelor's Degree in related field with relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas

Additional skills:
Proven successful project management leadership skills with ability to meet deadlines on multiple projects
Proficient in Microsoft Office Suite and related tools and systems (e.g., CTMS)
Proficient facilitation and presentation skills
Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
Excellent problem-solving, organizational, analytical and critical thinking skills
Ability to work positively through confrontation and/or conflicting ideas
Extensive understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, CFR 820, Canadian Medical Device Regulation (CMDR), EU MDD/MDR)
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
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of study management 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
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 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 $106,000 to $151,000 (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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