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Scientific. Clinical. Software Engineering

Senior Contracts Manager

New Jersey All, NJ

Job Type: Clinical Job Number: JN -042020-26760 Region: New Jersey All

Job Description

  • Create, negotiate and execute all study contracts, contract amendments, and budgets required for Clinical Trials (Phases I-III)
  • Develop CTA per patient budgets using Grant Manager
  • Draft study specific CTA templates
  • Finalize CTA templates and per patient budgets with study teams
  • Negotiate and establish pre-approval and approval workflows; review roles, task timelines and responsibilities; and negotiation parameters with study teams
  • Draft, negotiate, and execute site specific CTAs within established study timelines and study budgets
  • Develop, draft, and negotiate CTA amendments within established study budgets
  • Assist with managing the Data Driven Payment process for assigned studies
  • Lead and coordinate CTA management for large studies
  • Lead and coordinate CTA management for all studies within a project
  • Draft, negotiate, and execute contracts and contract amendments for studies
  • Ensure contracts are executed within fair market standards as appropriate
  • Answer questions and resolve problems concerning all assigned studies and individual contracts
  • Track workflow and contract cost for all assigned studies and individual contracts
  • Engage in process improvement initiatives both inside and outside the Contracts Management Group
  • Provide some mentoring to junior associates within the Contracts Management Group
  • Assist with developing and maintaining Contract Management Group procedures for contract management as needed
  • Support developing processes, standard templates, and quality definitions and metrics as appropriate


Requirements:


  • BA/BS Degree
  • 5 years of experience creating, negotiating and executing contracts in a pharmaceutical or biotech company or Contract Research Organization (CRO)
  • Knowledge of the pre-clinical, clinical, and peri-approval drug development process required
  • Advanced skills in Microsoft Outlook, Microsoft Word, Microsoft Excel and Microsoft Access
  • Experience using Adobe Acrobat Professional and Microsoft Office SharePoint
  • Proficiency with specialized industry databases such as GrantPlan/Grants Manager



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