Analyst, Clinical Contracts jobs in United States
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Edwards Lifesciences · 4 hours ago

Analyst, Clinical Contracts

Edwards Lifesciences is dedicated to transforming patient care through innovative technologies. The Clinical Contracts Analyst will negotiate and develop contracts associated with clinical trials, ensuring compliance with regulations and managing the lifecycle of contracts.

BiotechnologyHealth CareMedicalMedical Device
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Initiate, draft, redline, and negotiate 3rd party moderately complex clinical related contracts (e.g. legal contract language and budgets) based on substantial knowledge of financial/fair market value, regulatory and clinical requirements while demonstrating clinical knowledge. Recommend new/or revised language for contract templates
Identify risks (e.g. site incentives, legal issues, conflict of interest) and actively engage with management to provide recommendations for mitigation. Provide clinical input on functional contract terms, budgets, and scope of services to secure appropriate approvals in collaboration with key stakeholders (e.g. Clinical Affairs, Legal Compliance, Finance)
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’s 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 Legal Department’s RFA 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 as apply

Qualification

Contract negotiationClinical contracts experienceFinancial tracking/analysisRegulatory complianceMicrosoft Office SuiteMedical terminology knowledgeClinical research experienceProfessional interactionAttention to detailTeam collaboration

Required

Bachelors Degree in related field with 3 years experience of previous related work experience in contract negotiation/ administration and financial tracking/analysis against contracts required, or equivalent work experience based on Edwards criteria
Experience in healthcare related clinical contracts

Preferred

Strong experience drafting, reviewing, and negotiating clinical study contracts, including familiarity with terms and conditions, regulatory compliance, and stakeholder collaboration
Previous clinical research/clinical trial experience
Contract/paralegal certification
Proven expertise in Microsoft Office Suite including Word, PowerPoint, Excel, and SharePoint
Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
Understanding of regulatory requirements (e.g., CFR, GCP) and documents
Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build stable internal/external working relationships
Ability to interact professionally with all organizational levels
Strict attention to detail

Company

Edwards Lifesciences

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Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.

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 Company
Total Funding
unknown
2000-04-03IPO

Leadership Team

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Bernard J. Zovighian
Chief Executive Officer
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Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
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Company data provided by crunchbase