Clinical Data Associate II
 Advanced Clinical | |
 United States, California, Santa Monica | |
 Jan 31, 2025 | |
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OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Clinical Data Associate in Santa Monica, CA. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES * 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 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 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. EXPERIENCE BS degree with 5 years or MS degree with 3 years of technical experience in biologics/biopharma industry EDUCATION Bachelor's Degree or Master's degree in Data Analytics, Data Science, Applied Statistics or Applied Math, preferred To be a best-fit your strengths must include: * 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 About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |