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Years of Experience
Date Last Verified
Clinical Contracts Consultant Duties: 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 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
Qualifications: Bachelorâ€™s degree required. 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. drafting and negotiating clinical trial-related agreements, including complex. legal provisions. Experience managing projects within an organization. Strong organizational and planning skills and a meticulous attention to detail. Ability to effectively prioritize and multi-task. Ability to maintain focus and composure amid pressure and evolving priorities. Ability to identify and assess risk and communicate effectively. with internal team members, business partners and CROs. Excellent verbal and written interpersonal communication and relationship management skills. Ability to comprehend and manage business contracts and other complex documents. Self-motivated and able to work independently while exercising initiative, flexibility and good judgment. Strong desire to improve processes and grow. Ability to maintain and properly handle highly confidential information.
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