Analyst, Clinical Contracts
About The Position
Imagine how your ideas and expertise can change a patient's 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, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. 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 under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart 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. It's 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 negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts. This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.
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
Nice To Haves
- Bachelor's Degree in related field
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Miscellaneous Manufacturing
Number of Employees
5,001-10,000 employees
