Clinical Data Associate II
Apply NowCompany: Intelliswift
Location: Santa Monica, CA 90405
Description:
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.
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.