Business Analyst - Quality, Regulatory and Clinical - Contract
About The Position
Business Analyst - Qual, Reg, and Clinical Responsibilities: Collaborate with Quality, Regulatory and clinical business product owners and end users to understand data and analytics requirements. Craft functional requirements, technical requirements, stage to target mapping documentation Analyze and triage the business requirements to understand scope and data sources Own the creation of functional requirement document detailing the metrics, KPIs and related data sources as needed by the functional team. Create data mapping documents and break down epics and user stories for engineering teams Collaborate with the overall project manager and reporting workstream lead to manage scope and user feedback Collaborate with dev and engineering teams on delivery of data products Co-ordinate with testing and validation teams and manage testing cycles including user acceptance testing. Verify test scripts against the requirements captured Assist in implementing data governance standards through data cataloguing, meta data management, defining quality rules, etc. This is a W2 contract. 12 month contract. This role is hybrid - 2-3 days on site.
Requirements
- Experience with Business and data analysis in Pharmaceutical/Biotech Industry in GxP domain. Have a great understanding of 21CFRPart 11 and other GxP governing procedures
- Strong understanding of the Regulatory, Quality and Clinical functional areas including experience with clinical operations data, clinical patient data, quality management systems data, Regulatory and labeling data and reporting
- Ability to collaborate with business product owners and users to understand data and analytics requirements
- Strong understanding of agile methodology and ability to convert business requirements into implementation ready Epics and user stories
- Hands on knowledge with data querying, data analysis, data mining, reporting and analytics will be a plus
- Excellent verbal and written communication skills
- Willing to work in US EST time zone (half day or more overlap will be preferred)
- Strong foundation in metadata management concepts and data cataloging
- Familiarity with Data Governance processes and tool such as Collibra
- Ability to analyze data in the given domain to create concise descriptive metadata
- Skilled in use of python and other tools for managing the loading and analysis of metadata sets
Responsibilities
- Collaborate with Quality, Regulatory and clinical business product owners and end users to understand data and analytics requirements.
- Craft functional requirements, technical requirements, stage to target mapping documentation
- Analyze and triage the business requirements to understand scope and data sources
- Own the creation of functional requirement document detailing the metrics, KPIs and related data sources as needed by the functional team.
- Create data mapping documents and break down epics and user stories for engineering teams
- Collaborate with the overall project manager and reporting workstream lead to manage scope and user feedback
- Collaborate with dev and engineering teams on delivery of data products
- Co-ordinate with testing and validation teams and manage testing cycles including user acceptance testing. Verify test scripts against the requirements captured
- Assist in implementing data governance standards through data cataloguing, meta data management, defining quality rules, etc.
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What This Job Offers
Career Level
Mid Level
Education Level
No Education Listed
