CenterWatch

1+ months

Legal Counsel

WIRB-Copernicus Group (WCG)
Cary, NC 27513

General Information

Location: Cary, NC

Organization: Clintrax Global

Job Type: Full Time

Description and Requirements

The Legal Counsel leads the contract negotiation process with clinical trial sponsors and sites and facilitates the negotiation process.  The Legal Counsel role has the potential to work from home two (2) days per week subject to business needs, individual performance and/or other potential work requirements as defined in the Work From Home Policy.

EDUCATION REQUIREMENTS:

  • Juris Doctor (J. D.) from an ABA-accredited law school
    • Science background preferred

QUALIFICATIONS/EXPERIENCE:

  • Minimum of four (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. 

ESSENTIAL DUTIES/RESPONSIBILITIES:

  • 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.
  • Up to 10% travel may be required.

ABOUT US:

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 have provided services across 65 countries.

Posted: 2019-08-15 Expires: 2019-10-13

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Legal Counsel

WIRB-Copernicus Group (WCG)
Cary, NC 27513

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