Principal Clinical Information Analyst

Job Summary

We are seeking an experienced Principal Clinical Information Analyst to provide advanced analytical and data management support across clinical research and drug development programs. This role will be responsible for analyzing, interpreting, and managing complex clinical information to support clinical development, data quality, patient safety, and business decision-making.

The ideal candidate will have strong experience working with clinical trial data, clinical databases, data analysis, data standards, and cross-functional clinical teams within a pharmaceutical, biotechnology, CRO, or healthcare environment.

Key Responsibilities

• Lead the analysis, review, and interpretation of complex clinical information and clinical trial data.
• Develop and implement processes for collecting, reviewing, validating, and maintaining clinical data.
• Analyze clinical datasets to identify trends, discrepancies, data quality issues, and potential risks.
• Provide expert guidance on clinical data management and information analysis activities across multiple studies or programs.
• Partner with Clinical Operations, Clinical Data Management, Biostatistics, Statistical Programming, Medical Affairs, Safety, and Regulatory teams.
• Support clinical study teams with data-driven insights and recommendations.
• Review clinical databases, data listings, reports, and dashboards to ensure data accuracy, consistency, and completeness.
• Develop and maintain data queries, validation checks, metrics, and analytical reports.
• Identify data quality issues and lead resolution efforts with relevant stakeholders.
• Support database design, data review specifications, and clinical data standards.
• Contribute to the development and maintenance of Clinical Data Management Plans, Data Review Plans, and other clinical data documentation.
• Analyze data from multiple sources and support reconciliation of external and clinical data.
• Provide subject matter expertise on clinical information systems, data structures, and clinical research processes.
• Support study-level and program-level data review activities, including preparation for database lock.
• Develop and maintain dashboards, reports, and key performance indicators (KPIs) for clinical programs.
• Ensure clinical data and information are managed according to applicable SOPs, ICH-Google Cloud Platform, regulatory requirements, and data governance standards.
• Identify opportunities to improve clinical data processes, automation, reporting, and operational efficiency.
• Mentor junior analysts and provide technical and functional guidance to team members.
• Support audits, inspections, and other compliance activities as required.

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Data Science, Statistics, Computer Science, Health Informatics, or a related field.
• 7+ years of relevant experience in clinical data management, clinical information analysis, clinical research, or a related field.
• Strong understanding of clinical trial data and drug development processes.
• Demonstrated experience analyzing and interpreting complex clinical datasets.
• Strong knowledge of clinical data standards and data quality principles.
• Experience with clinical databases, EDC systems, and clinical data management platforms.
• Advanced analytical, problem-solving, and critical-thinking skills.
• Strong communication and stakeholder-management skills.
• Ability to work independently and lead complex cross-functional initiatives.
• Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience in pharmaceutical, biotechnology, CRO, or medical device organizations.
• Experience with Medidata Rave, Oracle Clinical/Clinical One, Veeva EDC, or similar EDC platforms.
• Knowledge of CDISC standards, including SDTM, CDASH, and ADaM.
• Experience with SAS, SQL, R, Python, Tableau, Power BI, or similar analytical/reporting tools.
• Experience with clinical data visualization and dashboard development.
• Familiarity with CTMS, eTMF, safety databases, and other clinical systems.
• Experience supporting database lock, study closeout, and regulatory submissions.
• Knowledge of ICH-Google Cloud Platform, FDA, EMA, and applicable clinical research regulations.
• Experience leading process improvement, automation, or data governance initiatives.
• Previous experience mentoring or providing functional leadership to clinical data teams.