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Legal Counsel Site Contracts ,

Epharmasolutions

Legal Counsel Site Contracts ,

Cary, NC
Full Time
Paid
  • Responsibilities

    Legal Counsel (Site Contracts) (Cary, NC) Legal Counsel (Site Contracts) (Cary, NC) Clintrax Global, Inc., a member of the WIRB-Copernicus Group family, specializes in the negotiation of clinical trial contracts and budgets between biopharmaceutical companies, contract research organizations (CROs) and investigator sites around the world. Clintrax Global has accelerated hundreds of clinical trials since its inception. Supported by technology-driven processes and a network of international attorneys, we provided services across 65 countries. The Legal Counsel provides advice, research and communication services on clinical contract matters to internal and external customers. Additionally, the Legal Counsel Manager leads the contract negotiation process with clinical trial sponsors and sites. ESSENTIAL DUTIES/RESPONSIBILITIES: 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. Accurately plan to achieve fully executed contracts in a timely manner. Oversee the negotiation of contract terms, pricing and payment schedule, ensuring that the agreements with investigative sites are aligned with clients interests on a global level. Oversee direct activities of Contracts Analysts and Project Associate Teams. This will include: Lead team to ensure goals and objectives are met or exceeded. Responsible for obtaining desired results from team. Ensure internal policies and procedures are followed by staff. Implement performance action plans as well as handle personnel issues, including disciplinary activities. EDUCATION REQUIREMENTS: Juris Doctor (J. D.) from an ABA-accredited law school RELATED DUTIES/RESPONSIBILITIES: Stay abreast of changes in regulatory and legal compliance standards and update internal and external clients as required. Other duties as required and assigned by General Counsel or President. These may, on occasion, be unrelated to the position described here, including duties otherwise assigned to Contracts Analysts. QUALIFICATIONS/EXPERIENCE: Minimum of three years of clinical contracting experience. Current, active admission to any state bar. Advanced skills in latest software programs such as Microsoft Word, Excel, Outlook, and Adobe Acrobat. Understanding of key legal, financial, legislative and regulatory issues related to global clinical trials and associated contracting with clinical sites. Highly developed interpersonal and communicative skills to interact effectively with stakeholders both internal and external. A passion for providing excellent client service. Demonstrates a willingness to be successful during changes or when flexibility is required. WCG is proud to be an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law. This is a full time-exempt position Visit Careers at WIRB-Copernicus Group Subscribe to be notified of new jobs If we don't have an open position that fits you, feel free to subscribe to our Talent Team email! Enter your name, email address and position(s) you're interested in, and whenever we open a new position matching your criteria we'll notify you immediately. * First name: * Last name: * Email address: * Send me openings in these areas: WIRB-Copernicus Group Western Institutional Review Board IRBNet Copernicus Group Independent Review Board Midlands Independent Review Board Aspire Independent Review Board New England Independent Review Board ePharmaSolutions Clintrax Global ProPhase ThreeWire MedAvante MedAvante-ProPhase Vigilare International I'm interested in: Management Non-mgt Subscribe Share this job Apply Now Leave this field blank Personal Information * First name * Last name * Email * Address * City * State Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District Of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Alberta British Columbia Manitoba New Brunswick Newfoundland Northwest Territories Nova Scotia Nunavut Ontario Prince Edward Island Quebec Saskatchewan Yukon Territory

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  • Industry
    Hospital and Health Care