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.
Able to analyze complex data to identify trends, patterns, and insights utilizing modern IT tooling.
Any relevant certifications (e.g., CBAP, PMI-PBA) or formal training in business analysis and solution development
Proficiency in using analytical tools and software for data analysis.
Ability to troubleshoot issues and implement effective resolutions.
Understanding of technical IT issues to organize discussions with internal and external technical specialists. Must be able to ensure best practices are used for each type of technology infrastructure: client/server, virtual environments (private, AWS, Azure), single or multi-tenant web-based Software as a Service (SaaS) solutions.