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Manager, Clinical Contracts The candidate will draft and negotiate a wide variety of agreements, including confidentiality agreements, clinical trial-related agreements, master services agreements, SOWs, work orders, consulting agreements, material transfer agreements, collaboration agreements, license agreements, and other vendor and services agreements in support of Five Primeâ€™s initiatives. Prepare clinical trial agreement template for use by US clinical trial sites and work with CROs to modify ex-US templates to address firm needs. Prepare negotiation parameters from time to time for use by CROs and other vendors supporting firmâ€™s clinical development activities. Collaborate with internal cross-functional teams and external parties to ensure timely turnaround and negotiation of agreements and, with respect to clinical trial agreements, start-up of study sites. Support business development transaction activities (e.g., in- and out-licensing and collaboration transactions) from time to time, including due diligence support. Manage special and ad hoc projects, as needed. Develop strong working relationships with functional groups, in particular with the Clinical Operations group, and project teams. Work without close supervision, initiate new assignments and identify ways to continuously improve templates, processes and operations.
Qualification and Experience
The candidate must have Bachelorâ€™s degree. Should have 6+ years of relevant experience as a clinical contracts associate/ clinical contracts manager and/or corporate paralegal, including in-house in the biotech industry. Experience drafting and negotiating a wide range of agreements, and extensive experience is needed drafting and negotiating clinical trial-related agreements, including complex legal provisions is must. Experience managing projects within an organization is required.
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