Edwards Lifesciences · 9 hours ago
Clinical Contracts Analyst
USA - California – Irvine
Full-time
Hybrid
Mid Level
$66K/yr - $90K/yr
3+ years expEdwards Lifesciences is a leader in medical innovations, focused on improving patient outcomes through clinical evidence. As a Clinical Contracts Analyst, you will draft and negotiate clinical-related contracts while ensuring compliance with regulations and guidelines. This role involves collaboration with various stakeholders to optimize contract terms and drive process improvements.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
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
Qualification
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
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
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
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