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 Manager, Clinical Contracts and Budgets, in compliance with applicable regulations and Edwards Lifesciences's policies, you will be responsible for the full clinical contract and/or budget negotiation lifecycle, partnering closely with clinical study teams, hospitals, research offices, and cross‑functional groups such as Legal, Finance, and Corporate Compliance to develop, negotiate, and lead the execution of a wide range of clinical contracts and budgets while applying both legal and clinical expertise.
This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine corporate location and have the ability to commute on required onsite days.
How you'll make an impact:
Manage and oversee the work of assigned team of Analyst level staff providing direction, mentorship, and guidance to develop and support their growth and ensure operational excellence. Help implement and foster a robust talent development plan in alignment with functional growth strategies of the department. Train and coach lower-level employees on basic clinical, budget, and contracts matters. Monitor staff’s progress (e.g., follow-up and output) to ensure that direct reports are following up with their assigned sites in the timelines identified by leadership.
Draft, negotiate, and execute the full clinical contract lifecycle for a variety of progressively complex contract types at high quality (e.g., Master Clinical Trial Agreements, Statements of Work (including budgets), Non-Disclosure Agreements, and/or Purchase Agreements, utilizing appropriate Edwards templates and systems). Assess needs for basic contract and budget amendments and provide guidance to stakeholders, make recommendations, and/or negotiate changes to terms and conditions while mitigating risks to the company.
Identify and mitigate risks with low, moderate, and high exposure to the company and create and implement corrective action plans to prevent repeat of risks. Escalate contract delays, external and internal issues and hurdles in a timely manner to leadership and key stakeholders and suggest solutions.
Develop moderate-to-complex clinical study budgets (e.g. study) based upon fair market value assessments with in-depth understanding of clinical project scope in collaboration with clinical study leaders.
Provide input on basic legal-owned contract templates. Work cross-functionally in collaboration with Clinical Study Teams, Hospitals, Legal, Finance, and Compliance to develop and modify a wide range of clinical agreement templates. Ensure contracts are strategically aligned with regulatory requirements, budgetary goals, and study timelines to accelerate the delivery of innovative therapies to patients.
Other incidental duties assigned by Leadership.
What you'll need (Required):
Bachelor’s degree or equivalent in related field with 8 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes or equivalent work experience based on Edwards criteria.
Or master's degree or equivalent with 6 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes.
Ability to travel up to 5% domestically
What else we look for (Preferred):
Juris Doctor or equivalent with previous related experience with Clinical Study Agreements, Non-Disclosure Agreements. Experience in healthcare, clinical study related contracts and budgets.
Contract or paralegal certification
Demonstrated supervisory experience, including the ability to lead, mentor, and oversee the work of direct reports while fostering a high‑performing, collaborative team environment.
Proven expertise in Microsoft Office Suite and working proficiency with contract lifecycle management (CLM) systems.
Excellent written and verbal communication skills, including negotiating and relationship management, with the ability to drive alignment and achieve objectives.
Strong problem-solving and critical thinking abilities.
Extensive understanding of clinical study protocols, assessments, and imaging.
In-depth understanding of Master Clinical Trial Agreements, including terms and conditions.
Deep knowledge of medical terminology, healthcare compliance, and privacy regulations (e.g., HIPAA, Sunshine Act).
In-depth understanding of Master Clinical Trial Agreements, including terms and conditions.
Skilled in drafting legal language and proficient in redlining.
Experienced in telephone-based negotiations for contracts, terms, and budgets.
Ability to develop and integrate metrics that demonstrate the value of clinical contracts to the business
Provide support and guidance to team members during contract negotiations to identify optimal solutions.
Responsible for employee management activities such as hiring, performance development, and partnering with HR on employee relations.
Maintain strict attention to detail and stay current on healthcare regulations and industry trends, including Fair Market Value assessments and CPT codes.
Monitor key contract terms, expiration dates, and deliverables to ensure timely renewals and amendments.
Strong knowledge of clinical research operations and cross-functional collaboration.
Capable of managing competing priorities in a fast-paced environment and adapting to shifting business needs.
Ability to interact professionally across all organizational levels and influence cross-functional leadership to gain alignment.
Ability to manage and support a team, including training, coaching, and providing guidance tor staff on clinical, budget, and contract matters.
Comfortable working in a team environment and making recommendation to reach an optimal solution to a problem or negotiation.
Able to coordinate with senior internal and external stakeholders on significant matters and provide subject matter expertise and guidance to others.
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 $105,000 to $148,000 (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.
E
dwards 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.