Clinical Research

Sr. Clinical Systems Analyst Direct Hire MA

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Job ID: 14856 Direct Hire MA

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Exciting Clinical Systems Analyst role with a successful and growing mid-size biologics company here in Cambridge, MA!  This critical role will be a part of an exciting, growing team and function as the primary partner between IT and Clinical Development Operations teams.  Other highlights of the role include:

  • Partner with internal clients to analyze their business processes, identify gaps and pain points, then build and document user and system requirements to guide solutions selection.   Work with the business process owners to develop project charters and plans to identify resources and establish reasonable target delivery dates, and coordinate these to give projects the best chance of being delivered on time and within budget.
  • Manage solution selection process, oversee contracting and negotiations with clients, internal legal and finance teams, and vendors.
  • Track and manage all projects and initiatives through a project portfolio and other appropriate management tools.   Partner with business process owners to define and facilitate the implementation of the solution through conference room pilots, user acceptance testing and end user training.
  • During implementation, work with external parties when necessary to analyze, define and document data and information flows impacting clinical operations and data management.
  • Post-implementation, work in concert with the user community to actively manage and optimize solutions and processes through the system lifecycle.
  • Initial focus is specifically on solutions related to the Clinical Operations area. This will include but not be limited to, issues impacting clinical data management, statistical analysis, and data visualization.  Familiarity with the following solution platforms:  eTMF, data collection/processing of EDC, and safety data, data analysis tools. 

Requirements:

  • BS or BA degree in related field AND 7-9 years of industry experience, including the support of a clinical development group. 
  • 3+ years of program/project management experience in the biopharmaceutical industry.