Clinical Data Associate - II*

$66,560 - $76,960/Yr

Innova Corporation Co. Ltd - San Mateo, CA

Full-time - Mid Level

San Mateo, CA

10,001+ employees

Specialty Trade Contractors

About the position

The Clinical Data Associate - II position at Innova Solutions involves collaborating with Process Engineers and Statisticians to meet project deliverables in the Global Manufacturing Sciences and Technology team. The role focuses on authoring and approving Continued Process Verification reports, performing data verification, assisting in report authoring, and participating in regular project meetings. The ideal candidate will possess strong communication and problem-solving skills, along with a solid technical background in data analytics and statistical analysis.

Responsibilities

• Collaborate with Process Engineers and Statisticians to meet project deliverables.
• Author and approve Continued Process Verification (CPV) related reports such as Process Monitoring Reports (PMR) and Annual Product Reviews (APR).
• Perform data verification according to Client Standard Operating Procedures (SOP).
• Reproduce CPV statistical output using JMP scripts and review documents for accuracy.
• Assist with report authoring by populating graphs, tables, and attachments in Word templates.
• Extract and transform data from Excel or databases as needed.
• Attend and participate in regular meetings to review and track report progress.
• Assist with preparations for bi-monthly Process Monitoring Tier 4 meetings and take meeting minutes.

Requirements

• BS degree with 5 years or MS degree with 3 years of technical experience in biologics/biopharma or high-tech industry.
• Proficient in SQL, SAS or equivalent for data extraction and transcription.
• Proficient in JMP, SAS or equivalent for statistical analyses.
• 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, with the ability to network and interact with manufacturing sites in different time zones.
• Knowledge of data management and ability to manage projects and prioritize multiple projects.
• Familiarity with a Quality Management System (QMS) and its application in biotech.

Nice-to-haves

• BS or MS degree in Data Analytics, Data Science, Applied Statistics or Applied Math.

Benefits

• Medical & pharmacy coverage
• Dental/vision insurance
• 401(k)
• Health saving account (HSA)
• Flexible spending account (FSA)
• Life Insurance
• Pet Insurance
• Short term and Long term Disability
• Accident & Critical illness coverage
• Pre-paid legal & ID theft protection
• Sick time
• Employee Assistance Program (EAP)