Business Analyst/Business System Analyst
Location
Cambridge, MA | United States
Job description
Job Title: Business Analyst/Business System Analyst
Duration: 09+ Months
Location: Cambridge, MA 02139
Required Technical Knowledge/Experience/Skills:
- Strong understanding of agile concepts and certification in agile methodology
- Strong understanding of modern data systems and tools including data platforms,
- data warehouses, data lakes, data ingestion, distribution pipelines, and data
- analytics/visualization how to apply this knowledge to clinical and real-world data.
- Strong Pharma/Life Sciences experience with an in-depth understanding of
- Clinical Development and Operations processes
Strong understanding and working knowledge of:
- GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, ICH E6(R2)
- Clinical Trial Data (STDM, ADaM, DTD, eCTD/XML)
- Nonclinical Study Data (SEND)
- Safety Data (ISO/HL7 27953: E2B(r2), E2B(r3); ICSR, PADER, PSUR,DSUR)
- Experience working in a Computer System Validation (CSV) process and SDLC process.
- Understanding and experience with Pharma related Technology
Solutions/Platforms, including but not limited to:
- PV Safety Databases/Technologies, EDC Platforms, IRT Platforms,
- Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc.
- Strong understanding and experience designing solutions and working in and Azure and AWS Cloud Environments
- Understanding of software development processes and methodologies (e.g.,Agile, Scrum, Waterfall, SDLC).
- Certified and experienced in working within an agile framework e.g. SaFe and as part of an agile team.
- Able to work within Jira and is proficient in creating and managing Epics, User Stories and Tasks.
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