Senior Clinical Data Analyst

We are seeking an experienced Senior Clinical Data Coordinator / Clinical Data Analyst with 8+ years of experience in clinical data management and clinical research environments

Job Summary

We are seeking an experienced Senior Clinical Data Coordinator / Clinical Data Analyst with 5+ years of experience in clinical data management and clinical research environments.

The ideal candidate will have strong experience coordinating clinical data activities, reviewing and cleaning clinical trial data, identifying data discrepancies, supporting database management, and working closely with Clinical Operations, Data Management, Biostatistics, Medical, and other cross-functional teams.

The candidate should have a strong understanding of clinical trial processes, data quality, data review, query management, and clinical data standards.

Key Responsibilities

• Coordinate and support clinical data management activities across clinical studies.
• Review clinical trial data for completeness, accuracy, consistency, and quality.
• Perform ongoing data review and identify discrepancies, missing data, and data quality issues.
• Generate, review, and track data queries and coordinate resolution with clinical sites and study teams.
• Support clinical database development, testing, validation, and maintenance.
• Review electronic data capture (EDC) systems and clinical data collected from multiple sources.
• Perform data reconciliation between EDC and external data sources such as laboratories, ECG, imaging, ePRO/eCOA, and safety systems.
• Develop and maintain data review reports, data listings, and tracking reports.
• Support User Acceptance Testing (UAT) and system validation activities.
• Participate in database lock preparation and execution activities.
• Assist with clinical data cleaning and ensure study data are ready for analysis and database lock.
• Review and maintain clinical data management documentation, including Data Management Plans and data review specifications.
• Work closely with Clinical Data Managers, Clinical Research Associates (CRAs), Clinical Operations, Biostatistics, Medical Affairs, and Statistical Programming teams.
• Support study teams in resolving data-related issues and discrepancies.
• Monitor study data and communicate trends, risks, and outstanding issues to project stakeholders.
• Assist with development and maintenance of clinical data reports and dashboards.
• Ensure clinical data activities follow applicable SOPs, protocols, regulatory requirements, and industry standards.
• Participate in study team meetings and provide updates on data quality and data management activities.
• Support inspection readiness and provide documentation during audits or regulatory inspections when required.
• Maintain accurate documentation and tracking of clinical data activities throughout the study lifecycle.

Required Qualifications

• 5+ years of experience in Clinical Data Management, Clinical Data Coordination, Clinical Data Analysis, or a related clinical research function.
• Strong understanding of clinical trial data management processes.
• Experience working with EDC systems such as Medidata Rave, Oracle Clinical, Veeva, or similar platforms.
• Experience with clinical data review, discrepancy management, query generation, and resolution.
• Experience with data reconciliation and data cleaning activities.
• Strong knowledge of clinical research terminology and clinical trial lifecycle.
• Experience working with cross-functional clinical teams.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Strong attention to detail and ability to manage multiple studies/tasks simultaneously.

Preferred Qualifications

• Experience with Medidata Rave or other major EDC platforms.
• Knowledge of CDISC standards, including CDASH and SDTM.
• Experience with clinical data management systems and clinical trial databases.
• Experience with external data reconciliation.
• Experience with database lock activities.
• Familiarity with 21 CFR Part 11, GCP, and applicable FDA/ICH requirements.
• Experience with clinical data reporting and data visualization tools.
• Knowledge of SQL, SAS, Excel, or other data analysis tools is a plus.
• Experience in pharmaceutical, biotechnology, medical device, or CRO environments is preferred.

Education

Bachelor’s degree in Life Sciences, Clinical Research, Health Sciences, Pharmacy, Nursing, Data Analytics, Computer Science, or a related discipline.