Project Coordinator / Business Analyst
Company: Poxy Clinical
Posted on: November 22, 2022
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.
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
- 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
- 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
- Software validation, UAT script writing / testing.
- Excellent time management and organization skills
- Have sound problem resolution, judgment, and decision-making
- 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
- 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,
Keywords: Poxy Clinical, Cambridge , Project Coordinator / Business Analyst, Professions , Cambridge, Massachusetts
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