Clinical Contracts Analyst

Imagine how your ideas and expertise can change a patients 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 youll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients 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 underdiagnosed and undertreated. Edwards groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative lifechanging solution for patients by offering heart valve replacement without the need for openheart 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. Its 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 NonDisclosure 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 youll make an impact:

• Initiate draft redline and negotiate moderately complex clinicalrelated contracts (NonDisclosure Agreements Master Clinical Trial Agreements Scopes of Work Trial Purchase Agreements) based on substantial knowledge of policy and regulations governing clinical trials and Edwards 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 crossfunctional teams; present and implement process improvement plans to management and/or key stakeholders.

• Other duties may be assigned by leadership.

What youll need (Required):

• Bachelors 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 Edwards criteria.

• Experience in healthcarerelated contracts or equivalent work experience based on Edwards criteria.

What else we look for (Preferred):

• Contract or paralegal certification or equivalent work experience based on Edwards 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 crossfunctional 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 problemsolving organizational analytical and criticalthinking skills.

• Ability to work in a team environment including interdepartmental 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 fastpaced 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 $66000 to $90000 (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.