Business Analyst Quality, Regulatory and Clinical Contract

Boston, NH - USA

Monthly Salary: $ 75 - 85

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description

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.

Skills and Experience:

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

Pay Range

$75-$85/HR

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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No C2C or Third-Party Vendors

Required Experience:

Job DescriptionBusiness Analyst - Qual Reg and ClinicalResponsibilities: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 documentationAnaly...