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European Legal Counsel - Clinical Site Contracts
Refer job# QCVE147764
 
European Legal Counsel - Clinical Site Contracts DUTIES: Build and maintain excellent relationships with colleagues and clients. Provide expertise to clinical research organizations and pharmaceutical clients to develop localized contract templates and optimal jurisdiction-specific contracting processes. Partner with CRO and Sponsor stakeholders to identify site-, country- and study-specific legal intelligence and risks to clinical trial start-up, and develop risk mitigation strategies. Review and negotiate 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 primary legal point of contact for all assigned client contracts. Ability to oversee projects, review, evaluate, and define set plans to achieve business goals. As needed, perform contract management duties for study level oversight. As needed, support business development activities. Critical thinking: Problem solve at a strategic level, working with others to reach a resolution. Accurately plan to achieve timely results. Oversee other employees negotiation of investigator contracts and budgets. This task may include: Perform QC review of contracts prepared by the contract analysts. Responsible for resolving complex escalations from contract analysts. Ensure internal policies, procedures, and client expectations are followed by staff. Create and revise templates error-free documents for sponsor specific documents including contracts, budgets, amendments, and ancillary agreements, for final execution. Negotiate contract terms, pricing and payment schedule, ensuring that the agreements with investigative sites are aligned with clients interests. Deliver excellent customer service in managing and resolving issues between clients, sites and team.

REQUIREMENTS: JD Degree from an ABA-accredited law school or international equivalent. Science background preferred. 4+ years of clinical contracting experience in the pharmaceutical industry is required. Prior supervisory experience demonstrating leadership expertise preferred. Must have knowledge of regulations as they relate to research. Must have advanced knowledge of Adobe Acrobat and Microsoft Word, Excel, and Outlook. Attention to detail required in a highly regulated industry. Ability to work independently, and be a pro-active team player is required. Must possess excellent verbal and written communication skills in English. Ability to proof-read and detect errors in typing, spelling, grammar, syntax and punctuation required.
 
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