Principal Clinical Contract Analyst

Marlborough, MA 01752 | Contract

Post Date: 07/31/2018 Job ID: 81657 Specialty: Legal & Compliance

A manufacturing company in Marlborough, MA is seeking a Principal Clinical Contract Analyst to join their team. In this contract role, you will support the Global Regulatory and Privacy Legal group through preparation, review and negotiation of clinical study and privacy agreements and other related agreements and business documents across a global organization. This position works with local and international business partners at varying leadership levels to facilitate the contracting process. Apply today!

Responsibilities for the Principal Clinical Contract Analyst:
  • Prepare and review global clinical study and privacy agreements between company and third parties, and related agreements and documents
  • Coordinate review and input from appropriate business unit employees as needed to complete contracting documents
  • Serve as first point of contact for internal business unit employees and Contract Research Organization ("CRO") legal teams in relation to escalations of clinical study agreement-related legal queries
  • Facilitate the on-boarding of CRO legal teams to ensure guidelines are communicated and understood; ensure compliance with such guidelines
  • Work in conjunction with Global Regulatory Legal counsel, ensure contract activity and administration is in accordance with company policies, legal requirements and third party specifications
  • Assist in the development and maintenance of processes and procedures to maintain compliance with company policies and health care laws, regulations and guidelines
  • Work to ensure appropriate policy and operational implementation of the requirements under HIPAA, including negotiation of Business Associate Agreements with covered entities, business associates, vendors and subcontractors
  • Support Legal counsel in implementing company global privacy projects
  • Identify opportunities to improve the efficiency and effectiveness of personally identifiable health information data protection, privacy and training policies and standard operating procedures
Requirements for the Principal Clinical Contract Analyst:
  • Bachelor’ s Degree
  • 5+ years of experience in contracts management/administration, negotiation, and/or paralegal
  • Excellent writing, proofreading, and editing skills
  • Ability to communicate via telecommunication and in person
  • Ability to interact professionally with all levels of management, multiple geographies, internal subject matter experts, legal staff, vendors, and clients
  • Ability to prioritize and complete daily workload and projects with minimal supervision and in accordance with deadlines and shifting priorities
  • Ability to communicate and manage personal project timelines and responsibilities
  • Strong organizational and administrative skills
  • Strong computer skills (including Microsoft Office and Adobe software)
  • Ability to synthesize information from a variety of sources and present it in a meaningful and concise way
  • Basic understanding of contract law, types, terms and conditions, legal requirements, and negotiation process
  • Proficiency in drafting contract language without the assistance of content management tools and/or software
  • Ability to read, draft and understand contractual terms; strong experience in redlining and negotiating agreements 
  • Ability to prioritize, adapt and work with cross-functional teams in a dynamic global work environment under limited supervision
  • Practical and business-minded approach to contract negotiation
  • Contribute to various internal operations projects (i.e., form templates, policies)
  • Advanced understanding of HIPAA and other applicable U.S. privacy laws (federal and state) 
  • Business Associate Contract drafting and negotiation skills
  • Experience reviewing, revising and negotiating Data Use Agreements preferred
  • Must be eligible to work in the U.S. without sponsorship                     

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