Atrium · 11 hours ago
Business Analyst - Quality, Regulatory and Clinical - Contract
US-MA-Boston
Full-time, Contract
Hybrid
Mid Level
$75/hr - $85/hrAtrium is a staffing agency seeking a Business Analyst for a contract role at Vertex Pharmaceuticals. The position involves collaborating with Quality, Regulatory, and Clinical teams to gather data requirements, create functional documentation, and manage testing cycles to ensure compliance with data governance standards.
Real Estate
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
Qualification
Required
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)
Tools: Veeva QMS, DMS, Veeva RIM, Veeva EDC, Veeva Clinical, Argus, JIRA, ALM, Power BI, Snowflake, Oracle DB, SQL, Microsoft office suite
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
Benefits
Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
This role will be eligible for overtime pay, in accordance with federal and state requirements.
Company
Atrium
Atrium is a global WBENC-certified Talent Solutions and Extended Workforce Management leader.
Founded in 1946
201-500 employees
H1B Sponsorship
Atrium has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Caylon Joiner
Talent Acquisition Partner
Shannon Mooney
Managing Director, Strategic Partnerships
Company data provided by crunchbase