Edwards Lifesciences

Clinical Contracts Analyst

Edwards Lifesciences

full-time

Posted on:

Location Type: Hybrid

Location: Irvine • California • 🇺🇸 United States

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Salary

💰 $66,000 - $90,000 per year

Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Negotiate and develop contracts associated with clinical trials
  • Ensure contracts comply with regulations and manage the lifecycle of contracts
  • Initiate, draft, redline, and negotiate 3rd party moderately complex clinical related contracts 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
  • 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
  • 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.

Requirements

  • 3 years experience of previous related work experience in contract negotiation/ administration and financial tracking/analysis against contracts
  • Experience in healthcare related clinical contracts
  • Bachelor's Degree in related field (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 (preferred)
  • Contract/paralegal certification (preferred)
  • 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)
  • 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.
Benefits
  • COVID Vaccination Requirement

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
contract negotiationcontract administrationfinancial trackingclinical study contractsregulatory compliancestakeholder collaborationcontract amendmentsprocess improvementmedical terminologyregulatory requirements
Soft skills
attention to detailteamworkrelationship buildingprofessional interactioncommunication
Certifications
contract certificationparalegal certification
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