Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As the Director of Clinical Project Management, you will be responsible for managing the strategic direction of clinical trials activities and ensuring all applicable regulatory requirements are met. This is an in-office based role, selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days for a hybrid work schedule.
How you'll make an impact
Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for high-profile, larger and more complex clinical trials 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 high-profile, larger and more complex projects for multiple clinical studies and initiatives. Determine clinical trial resources and set priorities for projects
Manage project status and appropriate communication both internally and externally including key opinion leaders. Present trial information at executive and/or industry conferences
Analyze trial performance to plan and develop corrective actions. Anticipate and communicate study risks and lead in the implementation of mitigation strategies
Build an effective and efficient clinical project team. Provide mentoring and coaching to other project team members.
Oversee the selection of clinical vendors and study sites
Manage and oversee the preparation of clinical portions of IDE and PMA submissions
What you'll need (Required):
Bachelor's Degree in related field
12 years of industry related clinical trial management work experience or
8 years of industry related clinical trial management work experience with an earned Master's Degree in related field
Ability to travel up to 15% for meetings, conferences, clinical site visits
Covid Vaccination
What else we look for (Preferred):
Experience with clinical trial execution in the areas of structural heart therapeutic area or cardiovascular class III medical devices
Direct people management experience, including remote workforce
Study management experience managing complex clinical studies, preferably early feasibility studies
Prior clinical research experience with Class III Medical Devices including PMA, IDE, and 510k
Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), Microsoft Project
For California, the base pay range for this position is $152,000 to $210,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.