Edwards Lifesciences
Overview
Analyst, Clinical Contracts role at Edwards Lifesciences. What you’ll do
Negotiate and develop contracts associated with clinical trials, ensuring compliance with regulations and managing the contract lifecycle. Draft, redline, and negotiate 3rd party clinical contracts (including legal language and budgets) with knowledge of financial/fair market value, regulatory and clinical requirements; recommend language changes for templates. Identify risks (e.g., site incentives, legal issues, conflicts of interest) and collaborate with management to mitigate; provide clinical input on terms, budgets, and scope of services to secure approvals with key stakeholders. Analyze need for contract amendments or renewals and negotiate changes as needed. Identify project timeline risks and impact on deliverables and workload of stakeholders across Legal Compliance, risk management, and related teams. Submit final draft and supporting documents through the Legal Department’s RFA system for approval and obtain necessary signatures within authority. Identify opportunities for process improvements and collaborate with cross-functional teams to implement improvements. Other duties as assigned. Qualifications
Required: 3 years of experience in contract negotiation/administration and financial tracking/analysis against contracts Experience in healthcare-related clinical contracts Preferred qualifications
Bachelor e2 4s Degree in related field Experience drafting, reviewing, and negotiating clinical study contracts, including terms, regulatory compliance, and stakeholder collaboration Previous clinical research/clinical trial experience Contract/paralegal certification Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel, SharePoint) Moderate knowledge of medical terminology and healthcare compliance/privacy (e.g., HIPAA, Sunshine Act) Understanding of regulatory requirements (e.g., CFR, GCP) and related documents Ability to work in a team and build internal/external relationships Attention to detail Working arrangement
Hybrid role (office and remote). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and be able to commute on required onsite days. Compensation and benefits
For California, base pay range is $66,000 to $90,000 (highly experienced). Final pay depends on qualifications, education, and experience. Applications accepted while posted on our Careers site. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID vaccination requirement: All patient-facing and in-hospital positions require COVID-19 vaccination. If hired, you may be required to provide proof of vaccination unless a medical or religious accommodation is granted. This requirement does not apply where prohibited by law. Job details
Seniority level: Not Applicable Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Medical Equipment Manufacturing
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Analyst, Clinical Contracts role at Edwards Lifesciences. What you’ll do
Negotiate and develop contracts associated with clinical trials, ensuring compliance with regulations and managing the contract lifecycle. Draft, redline, and negotiate 3rd party clinical contracts (including legal language and budgets) with knowledge of financial/fair market value, regulatory and clinical requirements; recommend language changes for templates. Identify risks (e.g., site incentives, legal issues, conflicts of interest) and collaborate with management to mitigate; provide clinical input on terms, budgets, and scope of services to secure approvals with key stakeholders. Analyze need for contract amendments or renewals and negotiate changes as needed. Identify project timeline risks and impact on deliverables and workload of stakeholders across Legal Compliance, risk management, and related teams. Submit final draft and supporting documents through the Legal Department’s RFA system for approval and obtain necessary signatures within authority. Identify opportunities for process improvements and collaborate with cross-functional teams to implement improvements. Other duties as assigned. Qualifications
Required: 3 years of experience in contract negotiation/administration and financial tracking/analysis against contracts Experience in healthcare-related clinical contracts Preferred qualifications
Bachelor e2 4s Degree in related field Experience drafting, reviewing, and negotiating clinical study contracts, including terms, regulatory compliance, and stakeholder collaboration Previous clinical research/clinical trial experience Contract/paralegal certification Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel, SharePoint) Moderate knowledge of medical terminology and healthcare compliance/privacy (e.g., HIPAA, Sunshine Act) Understanding of regulatory requirements (e.g., CFR, GCP) and related documents Ability to work in a team and build internal/external relationships Attention to detail Working arrangement
Hybrid role (office and remote). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and be able to commute on required onsite days. Compensation and benefits
For California, base pay range is $66,000 to $90,000 (highly experienced). Final pay depends on qualifications, education, and experience. Applications accepted while posted on our Careers site. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID vaccination requirement: All patient-facing and in-hospital positions require COVID-19 vaccination. If hired, you may be required to provide proof of vaccination unless a medical or religious accommodation is granted. This requirement does not apply where prohibited by law. Job details
Seniority level: Not Applicable Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Medical Equipment Manufacturing
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