What are the responsibilities and job description for the Clinical Data Associate position at Cube Hub Inc.?
Job Title : Clinical Data Associate
Job Location : SANTA MONICA, California, Need Local candidates
Job Duration : 6 months
Job Description
Works collaboratively with Process Engineers and Statisticians in Global Manufacturing Sciences and Technology (GMSAT), Statistical Sciences & Analytics (SS&A) team to meet project deliverables and timelines to author and approve Continued Process Verification (CPV) related reports, such as Process Monitoring Reports (PMR) and Annual Product Reviews (APR).
Performs Data Verification requirements per Kite’s Standard Operating Procedures ( SOP ), e.g., reproduces all CPV statistical output using JMP scripts, reviews documents for data and information accuracy, notifies author of errors and ensures corrections are made prior to approval and completes sign offs in QMS .
Assists with report authoring by populating graphs, tables and attachments in Word templates and identifying deviations using
Extracts and transforms data from excel or databases, as needed. Attends and participates in regular meetings to review and track report progress.
Assists with the preparations for bi-monthly Process Monitoring Tier 4 meetings, attends meetings and takes meeting minutes.
Must be able to effectively communicate and possess good problem solving as well as people / project leadership skills.
Requirements and Preferred Qualifications :
- BS degree with 5 years or MS degree with 3 years of technical experience in biologics / biopharma, high-tech industry
o BS or MS degree in Data Analytics, Data Science, Applied Statistics or Applied Math, preferred
Project Work :
1. Report Authoring :
a. PMRs : pre-populate tables (including deviation tables) and graphs
b. Control Limits : Manage and prepare data, compute and propose statistical limits and assist with report authoring
2. Report Verification :
a. PMRs : raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
b. APRs : raw data, figure and table formats, re-run all charts, check control limits, tables, statistics summaries and deviations against original data sources and metadata files.
c. Control limits : verify analytics approaches uses, re-run all analysis, verify updated limits.
3. Tier 4 Meetings : a. Take minutes
b. Cross-site comparison prep : prepare data, generate outputs from JMP scripts and update the slide deck.
