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Clinical Contracts Analyst

Edwards Lifesciences

Irvine, CA

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JOB DETAILS
SALARY
$66,000–$90,000 Per Year
SKILLS
Analysis Skills, Budgeting, Cardiac Surgery, Clinical Assessment, Clinical Practices/Protocols, Clinical Support, Clinical Trial, Clinical Trial Management, Communication Skills, Contract Analysis, Contract Approval, Contract Creation, Contract Management, Contract Negotiation, Detail Oriented, Documentation, Establish Priorities, GCP (Good Clinical Practices), Healthcare, Healthcare Providers, Interpersonal Skills, Leadership, Legal, Medical Equipment, Microsoft Access Database, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft SharePoint, Microsoft Word, Negotiation Skills, Non-Disclosures, Paralegal, Patient Care, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Public/Media/Press/Analyst Relations, Regulations, Regulatory Compliance, Risk Analysis, Risk Management, Statement of Work (SOW), Team Player, Vaccination, Writing Skills
LOCATION
Irvine, CA
POSTED
30+ days ago
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 Analyst, you will draft, negotiate, and develop Non‑Disclosure Agreements, Master Clinical Trial Agreements, Scopes of Work, and Trial Purchase Agreements for clinical trials, ensuring all terms and conditions comply with applicable regulations and guidelines.


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: ​


+ Initiate, draft, redline, and negotiate moderately complex clinical‑related contracts (Non‑Disclosure Agreements, Master Clinical Trial Agreements, Scopes of Work, Trial Purchase Agreements) based on substantial knowledge of policy and regulations governing clinical trials and Edward's policy.

+ Identify risks (e.g., site incentives, legal issues, conflicts of interest) and actively engage with management to provide recommendations for mitigation. Provide clinical input on functional contract terms.

+ Analyze need for contract amendments or renewals and make recommendations and/or negotiate changes to terms and conditions.

+ Identify risk associated with project timelines set by project teams, impacting team deliverables and timelines, and key stakeholders’ workload (e.g., Legal Compliance, Legal Contracts, Legal Privacy, and Risk Management) based on revised timelines.

+ Submit proposed final draft and supporting documentation through ECLM or CLM system for contract approval and secure appropriate signatures within specified signing authority.

+ Identify opportunities for process improvement in collaboration with cross‑functional teams; present and implement process improvement plans to management and/or key stakeholders.

+ Other duties may be assigned by leadership.


What you'll need (Required):


+ Bachelor’s degree in related field with 3 years of previous related work experience in contract negotiation/administration tracking/analysis against contracts, or equivalent work experience based on Edward's criteria.

+ Experience in healthcare‑related contracts or equivalent work experience based on Edward's criteria.


What else we look for (Preferred): ​


+ Contract or paralegal certification or equivalent work experience based on Edward's criteria.

+ Strong experience with drafting and routing contracts in a Contract Life Cycle Management System (CLM).

+ Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, Excel, and SharePoint.

+ Extensive knowledge and understanding of Edwards policies, procedures, and guidelines relevant to contract negotiation and administration.

+ Extensive understanding of the NDA, MCTA, SOW, and TPA templates and drafting to negotiate and redline contractual language.

+ Understanding of medical device trials, GCP, and compliance requirements.

+ Ability to collaborate with the Study Team and Clinical Project Manager to strategize on site prioritization and enable fast site activation.

+ Partner and plan with the Study Team to plan accordingly on the timeline of the negotiation process as well as plan for the final execution date as this relates to site activation.

+ Partner with the Budget Analyst to coordinate when the final execution date will be set for the site based on negotiation timelines and plans for finalization.

+ Initiate, draft, redline, and negotiate moderately complex terms, conditions, payment, and budget terms in order to support the internal Site Payment teams as well as the Study Team on trial cost and payment.

+ Identify opportunities for process improvement independently or in collaboration with cross‑functional teams; present and implement process improvement plans to management and/or key stakeholders.

+ Work with the Legal Partner to address terms and conditions that are outside internal approvals, seeking guidance for an appropriate fallback clause on contracts.

+ Analyze need for contract amendments due to major protocol changes aligning with internal work instructions and practices.

+ Identify risk associated with project timelines set by project teams, impacting team deliverables and timelines, and key stakeholders’ workload (e.g., Legal Compliance) based on revised timelines.

+ Advanced written and verbal communication skills and interpersonal relationship skills.

+ Proven problem‑solving, organizational, analytical, and critical‑thinking skills.

+ Ability to work in a team environment, including inter‑departmental teams and representing the organization on specific projects.

+ Ability to build internal/external working relationships.

+ Strict attention to detail.

+ Ability to manage competing priorities in a fast‑paced environment.

+ Ability to interact professionally with all organizational levels.


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 (CA), the base pay range for this position is $66,000 to $90,000 (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.

About the Company

E

Edwards Lifesciences