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Clinical Data Associate II

Job ID: 25-08458
Job Title: Clinical Data Associate
Duration: 6 months, 40 hrs/week
Location: Santa Monica, CA

Continued Process Verification (CPV) and JMP software experience is a MUST

Assists with report authoring by populating graphs, tables and attachments in Word templates and identifying deviations using QMS. 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
• Proficient in SQL, SAS or equivalent for data extraction and transcription
• Proficient in JMP, SAS or equivalent for statistical analyses and familiar with Statistical Quality Control techniques, e.g., SPC and Process Capability.
• Knowledge of python code for report generation.
• Proficient in Microsoft Word and Excel
• Exceptional attention to detail with the ability to meet aggressive deadlines
• Good communication and documentation skills, ability to network and interact with manufacturing sites in different time zones
• Knowledge of data management and ability to manage project and prioritize multiple projects
• Familiarity with a Quality Management System (QMS) and how it is used in biotech

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.
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