Clinical Trial Operations Manager-Core Labs, Transcatheter Heart Valve

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 Clinical Operations Manager for our THV Core Labs team, you will be responsible for managing a team of in-house clinical research professionals and clinical related activities and setting up sites with adequate and appropriate training resources, site communications, and data security to provide a platform for study success.

The position will be on-site at our Irvine headquarter 4 days with 1 WFH day/week.

How you will make an impact:

• 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.

What you will need (required):

• 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
• Covid vaccination
• Ability to work on-site 4 days/week

What else we look for (preferred):

• Bachelor’s Degree in related field PLUS 8 years of relevant clinical trial operations/clinical research/clinical monitoring experience
• 1-2 years of leadership/management experience

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