Clinical Data Associate II

Clinical Data Associate II

Santa Monica, CA/Remote

Schedule: Standard Office Hours

Duration: 6-Month Contract

Pay:$30-35/ph



Job Responsibilities

In this role, you will manage and support various projects within a collaborative manufacturing sciences and technology environment. Key responsibilities include:

• Collaborating with Process Engineers and Statisticians to deliver project objectives, including the authoring and approval of Continued Process Verification (CPV) reports, such as Process Monitoring Reports (PMRs) and Annual Product Reviews (APRs).
• Performing data verification in alignment with standard operating procedures (SOPs), including reproducing statistical output, reviewing documentation for accuracy, notifying authors of discrepancies, and ensuring corrections are implemented.
• Assisting with report preparation by populating graphs, tables, and attachments in document templates and identifying deviations using quality management systems (QMS).
• Extracting and transforming data from Excel or databases as needed.
• Participating in regular meetings to review project progress and prepare for bi-monthly Process Monitoring meetings.
• Taking meeting minutes and supporting cross-site data comparisons by preparing datasets, generating outputs, and updating presentations.
• Communicating effectively and demonstrating strong problem-solving and project leadership skills.

Essential Duties and Job Functions

• Report Authoring:
  • Pre-populating tables (e.g., deviation tables) and graphs for PMRs.
  • Managing and preparing data to compute and propose control limits for statistical analyses.
• Report Verification:
  • Verifying raw data, figures, and tables; re-running charts; and cross-checking control limits and statistical summaries with original data sources.
  • Ensuring analytics methods are validated and updating control limits as necessary.
• Tier 4 Process Monitoring Meetings:
  • Preparing materials for cross-site comparisons and updating slide decks based on statistical analyses.
    • Taking and distributing detailed meeting minutes.
• Required Qualifications
  • Bachelor’s degree with 5+ years or Master’s degree with 3+ years of experience in biologics, biopharma, or a high-tech industry.
  • Degree in Data Analytics, Data Science, Applied Statistics, or Applied Math (preferred).
  • Proficiency in SQL, SAS (or equivalent) for data extraction.
  • Experience with JMP, SAS (or equivalent) for statistical analysis, including Statistical Quality Control techniques.
  • Familiarity with Python for report generation.
  • Advanced skills in Microsoft Word and Excel.
  • Strong attention to detail and the ability to meet tight deadlines.
  • Excellent communication and documentation skills, with the ability to collaborate across multiple time zones.
  • Knowledge of data management and experience managing multiple concurrent projects.
  • Familiarity with Quality Management Systems (QMS) in biotech settings.
• Preferred Skills
  • Familiarity with statistical process control (SPC) and process capability analysis.
  • Experience supporting cross-functional teams in a regulated industry.
  • Strong organizational, analytical, and critical thinking skills.

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