Clinical Contracts Manager, Vendors/Suppliers, Transcatheter Heart Valve

Clinical Contracts Manager, Vendors/Suppliers, Transcatheter Heart Valve, Irvine, CA

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 Contracts (Vendors & Suppliers) Manager for our THV team, you will be responsible for the full clinical contract lifecycle, and ongoing management of vendor/supplier and consultant contracts; including partnering closely with third parties, Legal, Finance, and Compliance teams to develop and manage the execution of a variety of clinical contracts while applying legal, contracting, and clinical expertise.

The position will be on-site at our Irvine headquarter 5 days/week and will turn to a hybrid working schedule after the completion of the first 6 months.

You will make an impact by…

• Managing and overseeing the work of assigned team within own function; helping implement and foster a robust talent development plan in alignment with functional growth strategies of the department
• Training and coaching lower-level employees on basic clinical and contracts matters; Monitoring staff’s progress (e.g., follow-up and output) to ensure that contracts analysts are following up with their assigned sites and/or vendors in the timelines identified by leadership
• Drafting, negotiating, and executing the full clinical contract lifecycle for a variety of progressively-complex contract types at high quality (e.g., clinical trial agreements including budgets, non-disclosure agreements, and/or vendor contracts including RFP process), utilizing appropriate Edwards & third-party systems
• Overseeing ongoing vendor lifecycle management, including new supplier onboarding, supplier qualification, COUPA activation/de-activation, annual supplier review/scorecards, and post-project review; collaborating with clinical stakeholders to identify and qualify new suppliers utilizing appropriate Edwards’ systems
• Assessing needs for basic contract and budget amendments and providing guidance to stakeholders, making recommendations, and/or negotiating changes to terms and conditions while mitigating risks to the company
• Identifying and mitigating risks with low to moderate exposure to the company and create corrective action plans to prevent repeat of risks; escalating contract delays, external and internal issues and hurdles in a timely manner to leadership and key stakeholders, and suggesting solutions
• Providing input on basic legal-owned contract templates

What you will need (Required):

• Bachelor's Degree in related field PLUS 8 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes
• 1-2 years of leadership/management experience

What else we look for (Preferred):

• Master’s Degree or Juris Doctor PLUS 6 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes
• Experience in healthcare related (clinical, HCP) contracts
• Experience in managing contract system change

Additional skills:

• Proven expertise in Microsoft Office Suite and related contract systems
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving and critical thinking skills
• Extensive understanding of clinical contracts procedures while defining team operating standards and ensuring essential procedures are followed based on