Clinical Operations Manager
4 weeks ago
Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
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.
This role is on-site at our Irvine headquarter full time 4 days with 1 WFH day/week.
**How you will make an impact**:
Lead clinical operation projects including quarterly audits, annual vendor reviews, etc. to support clinical studies and business initiatives
Oversee device management activities to ensure devices are shipped in a timely fashion for every case
Oversee trial training documents to ensure that we’re aligned with training matrix(es) and company SOPs
Monitors for the overall completeness and inspection readiness of the clinical trial master files
Provide guidance, mentorship and oversight to more junior clinical operations staff members
Manage the timely execution of key study milestones through management of performance metrics, to ensure effectiveness, LMS compliance, and TMF quality
Plan, oversee, and lead in the development of procedures and supportive training materials (e.g., work instructions, forms, templates and operational processes) that implement clinical process improvement
Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues in collaboration with cross functional and/or matrix teams
Facilitate the creation of training materials related to the planning and conduct of the trial for the internal research team. Conduct training for internal staff and coordinate and present at department team meetings
**What you will need (required)**:
Bachelor’s Degree in related field PLUS 8 years of relevant clinical trial operations/clinical research/clinical monitoring experience
**What else we look for (preferred)**:
Experience working in the medical device industry
1-2 years of project management leadership experience
Proven expertise in Microsoft Office Suite and related clinical tools and systems (e.g., Veeva, CTMS, RAVE)
Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
Excellent written and verbal communications skills, including negotiating and relationship management skills
Excellent interpersonal skills
Excellent critical thinking and problem solving skills
Ability to travel up to 15%
Ability to work on-site 4 days and 1 WFH day/week
Covid-19 vaccination
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 $115,000 to $150,000 (highly experienced).
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