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Project Coordinator / Business Analyst

Company: Poxy Clinical
Location: Cambridge
Posted on: November 22, 2022

Job Description:

Project Coordinator / Business Analyst (Full-Time, Hybrid-Remote and In-Office in Cambridge, MA)Note: Local Candidates based in Cambridge/Boston, MA area ONLY; we do not provide sponsorships.
We are seeking a Project Coordinator / Business Analyst to join our growing software consulting company. The candidate's primary responsibility is to lead meetings, follow-up on action items, provide test support, and provide training to clinical teams. A sharp, detail oriented, organized individual that takes initiative, has clear communication skills, ability to manage competing priorities / multi-task, and experience working in client facing roles is a must.
Primary Responsibilities:
Day-to-day responsibilities will require the candidate to manage RTSM / IRT software vendors, and Global Clinical teams to ensure all project deliverables are met. The candidate will be writing 60 pages of test scripts and play a role in reviewing, and making needed edits. Attention to detail and organization is a definite must.

  • Analyze study related documentation, including specifications, and clinical protocols.
  • Support UAT activities, including, but not limited to: training of UAT testers, creating test scripts, conducting review sessions, and providing UAT execution support, and review of test results documentation.
  • Provide issue resolution management (tracking UAT issues, deviation report drafting)
  • Ensure adherence to Regulatory requirements, including cGMP, 21 CFR Part 11, cGDP, Annex 13, as well as Poxy Clinical's internal SOPs and processes.
  • Application of software/test methodologies
  • Must be analytical / technical but able to communicate the information to large audience clearly
  • Familiarity of global clinical trials, drug development process, and clinical supply strategy / global IP distribution.
  • Software validation, UAT script writing / testing.
  • Excellent time management and organization skills
  • Have sound problem resolution, judgment, and decision-making abilities
    Other:
    • Full-time, 40 hours a week
    • Must be flexible with hours to support Global study teams
    • Local to Cambridge Boston, MA (relocation not offered)
    • Hybrid role (our office is based in Cambridge at CIC - 3 days a week, 2 days work from home)
    • Must have office desk, home office set-up.
    • NO work sponsorships; only considering GC holders or US Citizens
      Qualifications
      • Excellent verbal and written communication skills, problem solving skills, and attention to detail
      • Ability to prioritize and multi-task with competing priorities, and adapt to fast paced environment
      • Expertise in Microsoft Office Suite (Word, Excel, Powerpoint, Visio, Teams)

Keywords: Poxy Clinical, Cambridge , Project Coordinator / Business Analyst, Professions , Cambridge, Massachusetts

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