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Years of Experience
Date Last Verified
ProfileLegal Counsel The candidate will provide advice, research and communication services on clinical contract matters to internal and external customers. Will provide expertise to clinical research organizations and pharmaceutical clients to develop localized contract templates and optimal jurisdiction-specific contracting processes. Support a global team negotiating clinical contracts in multiple languages by providing guidance and appropriate escalation pathways. Train and mentor global team negotiating clinical contracts to appropriately apply client specific fallback guidance and to identify salient issues during the negotiation process. Engage with multiple client stakeholders to develop key relationships and ensure that executed agreements accurate reflect and advance client legal, clinical, compliance, and financial priorities. Partner with CRO and Sponsor stakeholders to identify site-, country- and study-specific contracting intelligence and risks to clinical trial start-up, and developing risk mitigation strategies. Review and negotiates special agreements, potentially including ICFs, master agreements, and site financial agreements in advance of full contract negotiations, when included in the scope of activities by the client. Serve as the legal primary point of contact for all assigned client contracts. Serve as liaison between Legal Department and Operations and external clients on contract matters including the drafting and review of contracts. Advise management on contract requirements and procedures. Provide legal advice and perform legal research for internal stakeholders pertaining to contractual and other issues that arise in and affect the business. Provide general legal analysis to the General Counsel and management team and make recommendations for best course of action under the given circumstances.
Qualification and Experience
The candidate should have Juris Doctor (J. D.) from an ABA-accredited law school. Must have 3+ years of clinical contracting experience. Must have Current, active admission to any state Bar. Advanced skills in latest software programs such as Microsoft Word, Excel, Outlook, and Adobe Acrobat is required. Must have understanding of key legal, financial, legislative and regulatory issues related to global clinical trials and associated contracting with clinical sites.