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Senior Clinical Contracts Analyst

1 month ago

Irvine, United States Edwards Lifesciences Full time

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 Senior Clinical Contracts Analyst, you will initiate, execute, administer contracts with third parties to support clinical trial operations and manage the lifecycle of contracts from initiation to completion or termination in compliance with applicable regulations and company policies. The position will be on-site at our Irvine headquarters 5 days/week.

How you'll make an impact:

  • Initiate, redline, and negotiate 3rd party complex contracts based on full knowledge of financial, regulatory and clinical requirements
  • Negotiate trial budgets with clinical sites to ensure compliance with company-approved guidelines and alignment with fair market value utilizing approved budget templates
  • Analyze need for contract amendments or renewals; evaluate prior terms and conditions, and make recommendations and/or negotiate changes within guidelines and regulations
  • Collaborate with key stakeholders to receive and provide receive guidance on contracts terms and conditions. Identify risks and communicate to key stakeholders of the company
  • Manage contracts administration through corporate-required platforms and department trackers, including status updates, repository maintenance, data input, report generation, and report analysis
  • Create budget, contract and letter templates, as requested by management; suggest changes to contractual terms and conditions associated with contract and budget templates
  • Provide training to incoming staff on simple and moderate contract matters and on EW policies and procedures
What you'll need (required):
  • Bachelor's Degree in related field
  • Minimum 5 years of previous related experience in contract preparation, negotiation, redlining, and budget negotiations
  • Experience in healthcare related contracts
What else we look for (preferred):
  • Previous clinical research/clinical trial experience
  • Strong budget negotiation experience
  • Contract or paralegal certification
Additional Skills:
  • Proven expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
  • Good written and verbal communication skills and interpersonal relationship skills
  • Demonstrated problem-solving and critical thinking skills
  • Moderate knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration
  • Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
  • Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents
  • Advanced proficiency in Microsoft Office Suite, including Excel, and Word
  • Ability to manage confidential information with discretion
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific project
  • Ability to build productive internal/external working relationships


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 $78,000 to $110,000 (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.