Business Data Analyst Clinical Manufacturing

Nexinfo Solutions - Foster City, CA

Full-time - Mid Level

Foster City, CA

Professional, Scientific, and Technical Services

About the position

The Business Data Analyst Clinical Manufacturing role is focused on leveraging data to enhance clinical operations, improve decision-making, and ensure compliance with regulatory standards. The position requires a detail-oriented individual with a strong background in data analytics, particularly in the clinical research or healthcare sectors, who can translate complex data into actionable insights.

Responsibilities

• Collect, clean, and analyze clinical and operational data from various sources.
• Develop and maintain dashboards, reports, and visualizations to support clinical teams in decision-making.
• Identify trends, patterns, and insights to optimize clinical workflows and improve patient outcomes.
• Work closely with clinical researchers, data scientists, and business stakeholders to understand data requirements.
• Translate business needs into technical requirements for data collection and reporting.
• Communicate insights and findings clearly to technical and non-technical stakeholders.
• Ensure data quality, integrity, and compliance with regulatory standards (e.g., HIPAA, GDPR).
• Design and implement processes for efficient data collection, storage, and retrieval.
• Maintain metadata, data dictionaries, and documentation.
• Analyze current clinical processes and identify opportunities for optimization through data-driven insights.
• Collaborate with IT and clinical teams to implement process improvements.
• Support clinical teams in meeting regulatory reporting requirements (e.g., FDA, EMA).
• Ensure data governance policies are adhered to and maintain audit readiness.
• Provide data analytics support for clinical trials, including patient enrolment metrics, trial monitoring, and outcome analysis.
• Assist in developing study protocols and statistical analysis plans (SAPs).

Requirements

• Bachelor's degree in data science, Computer Science, Biostatistics, Healthcare Administration, or a related field; advanced degree preferred.
• 8+ years of experience as a data analyst, preferably in clinical research or healthcare.
• Familiarity with clinical trial processes and regulations is a plus.
• Proficiency in data analysis tools and languages (e.g., SQL, Python, R).
• Experience with data visualization tools (e.g., Tableau, Power BI).
• Knowledge of databases, ETL processes, and data warehousing.
• Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) systems, and health information systems.
• Strong problem-solving skills and attention to detail.
• Excellent communication and presentation skills.
• Ability to work collaboratively with cross-functional teams.
• Understanding of regulatory requirements such as HIPAA, 21 CFR Part 11, and Google Cloud Platform (Good Clinical Practice).
• Experience with handling sensitive clinical data securely and ethically.
• Certification in data analytics (e.g., Certified Analytics Professional, SAS certification).
• Familiarity with machine learning techniques and their application in clinical research.
• Experience working with clinical datasets, including EHR/EMR systems and patient-reported outcomes.

Nice-to-haves

• Familiarity with clinical trial processes and regulations is a plus.
• Experience with machine learning techniques and their application in clinical research.