Clinical Data Analyst

Department : Clinical Operations/Clinical Data Management
Job Summary:

The Clinical Operations Data Specialist is responsible for managing, validating, and maintaining clinical trial data across various systems and tools used in Clinical Operations. This role supports data quality, consistency, and availability for real-time reporting, study oversight, and operational decision-making. The ideal candidate has strong attention to detail, experience working with clinical systems, and a solid understanding of clinical trial operations.

Key Responsibilities:

Data Management & Integrity:

• Ensure completeness, accuracy, and consistency of clinical trial data in systems such as CTMS, eTMF, EDC, IRT, and clinical dashboards.
• Perform data cleaning, validation checks, and discrepancy resolution in collaboration with clinical study teams.
• Conduct regular data audits to ensure compliance with internal and regulatory standards.

System & Tool Support:

• Manage and update study, site, and subject-level information in clinical systems (e.g., CTMS, eTMF).
• Support data imports/exports and work closely with IT/Clinical Systems teams to maintain data pipelines.
• Troubleshoot and resolve data-related issues, escalating where needed.

Reporting & Metrics:

• Generate and maintain operational reports and dashboards (e.g., enrollment, site performance, monitoring visits).
• Provide data to support KPIs, metrics, and risk-based monitoring initiatives.
• Assist in preparing reports for study team meetings, executive dashboards, and regulatory submissions.

Process Support & Compliance:

• Support implementation of data standards, SOPs, and best practices in clinical data handling.
• Ensure compliance with Google Cloud Platform, ICH, and company-specific data policies.
• Document data management activities and maintain data traceability.

Cross-functional Collaboration:

• Collaborate with Clinical Operations, Clinical Data Management, Biostatistics, and Regulatory Affairs.
• Serve as a point of contact for data-related queries from internal stakeholders or vendors.
• Participate in study team meetings to provide data updates and insights.

Qualifications:

• Bachelor's degree in Life Sciences, Health Informatics, Computer Science, or related field.
• 2 5 years of experience working with clinical data in the pharmaceutical, biotech, or CRO industry.
• Proficiency with clinical trial systems such as CTMS (e.g., Medidata, Veeva Vault), EDC, eTMF, and IRT.
• Strong skills in Excel, and experience with data visualization or reporting tools (e.g., Power BI, Tableau) is a plus.
• Understanding of clinical trial processes and regulatory guidelines (ICH-Google Cloud Platform, FDA, EMA).
• High attention to detail and accuracy with the ability to work independently and in teams.

Preferred Qualifications:

• Experience with data integration tools or querying languages (e.g., SQL).
• Knowledge of SDTM/CDISC data standards.
• Familiarity with risk-based monitoring and centralized monitoring practices.
• Experience with data migration or system implementation projects.