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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Legal Staff
Health Care
Litigation - Whistleblower - CFTC
Min 5 yrs required
Manager, Clinical Contracts - Transcatheter Heart Valve Duties: Responsible for timely contract execution to meet study enrollment expectations and for contracts maintenance to support ongoing studies. Partner with Legal, Finance and Compliance groups to review and process multi-site Clinical Study Agreements, Service Provider Agreements, and other agreements related to new and on-going THV studies. Reviews, analyzes, redlines, and negotiates all site and service provider contracts (including amendments) utilizing Edwards’ language requirements and templates. Manage assigned contracts from initiation to execution; provides contracts backup support as needed to Sr. Manager & Director. Manage contract obligations and financial milestones. Manage contract expiration dates and analyze need for contract amendments or renewals; make recommendations, and/or negotiate changes, to terms and conditions. Investigate and summarize fair market value assessments for each contract. Works collaboratively with various departments in order to process contract-related requests, including Edwards†Legal, and THV Finance, study managers, field team, and clinical group directors. Review, negotiate, draft, analyze, and execute contracts which includes, but is not limited to: Clinical Study Agreements, Non-Disclosure Agreements, Service Provider Agreements, Clinical and Service Provider Amendments, Letters of termination or expiration, Research Agreements, Educational Research Agreements, Informed Consent Forms. Works collaboratively with various departments in order to process contract-related requests, including Edwards†Legal, and THV Finance, study managers, field team, and clinical group directors. Works with Senior Contract Manager to ensure contract templates are updated. Provides alternate language suggestions for existing contracts or new templates; collaborate with Edwards Legal and THV Clinical Operations management to draft and develop acceptable alternative contract language for contract templates. Utilizes contracts management system to manage assigned workload and to run reports for analysis purposes. Extracts legally pertinent contract provisions and summarizes applicable clauses and terms for special projects. Monitors monthly expiration report; contacts business unit requestor to determine contract extension; contacts Service Provider to extend term or draft letter of expiration/termination.
Qualification and Experience
Qualifications: Bachelor degree is required; Paralegal certification or J.D. degree preferred. 5+ years experience preferably working with Clinical Study Agreements, Informed Consents, Service Provider contracts along with knowledge of supplier qualifications processes. Background in medical device, regulatory or healthcare lifesciences is also preferred. Must have experience negotiating contracts, a working knowledge of all legal aspects of contracting and the ability to understand contract language and quickly identify/communicate any risks or liabilities. Must have a demonstrated expertise in coordinating and negotiating contract terms and conditions.
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