Business / Systems Analysis

Lead Business Systems Analyst, GXP Direct Hire MA

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Job ID: 14676 Direct Hire MA

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Exciting growth opportunity for Business Systems Analyst with pharmaceutical experience!  Mid-Size Biologics company here in Cambridge, MA is expanding and looking to bring on board a Sr./Lead Business Systems Analyst to support their Clinical Operations, Regulatory and Quality groups (CRQ).  Reporting to the Associate Director of IT CRQ, this role will support in managing both ongoing and future projects within the CRQ Portfolio. The Sr. BSA will be the right hand person to the AD, IT CRQ and will have a wealth of opportunity to grow within the organization and team!  This role will initially include but not be limited to: EDMS, LMS, QMS (CAPA/Audit), and Literature Management. Other responsibilities include but not limited to:

  • Ability to effectively partner with Business Process Owners in driving project selection and implementation through effective gathering and analysis of user requirements.
  • Manage product selection process through appropriate levels of due diligence (RFI or RFP).
  • Oversee contracting and negotiations, and manage product vendor.
  • Work and manage external consultants as needed.
  • Manage a project team through the project lifecycle, providing guidance and support as necessary through all phases.  Track and manage project using PMO tools ensuring that projects are delivered in a timely fashion within budget.
  • Manage and track validation deliverables through the project implementation period
  • Work in concert with the user community to actively manage and optimize solutions through their lifecycle

Requirements:

  • BS/BA and 4-8 years of relevant industry, pharmaceutical experience. 
  • Knowledge/experience in managing/implementing GxP projects and systems.  Experience working within the framework of a validated project implementation plan and knowledge of validation deliverables
  • Knowledge/experience of content management and training management, quality management, eTMF, submission management, data collection/processing of EDC, and safety data