Senior Clinical Data Analyst

Job Summary

The Clinical Data Management Associate will support the Data Management Lead (DML) in the planning, setup, execution, monitoring, and closeout of clinical studies. The role is responsible for database build activities, data review, vendor oversight, study documentation, quality management, and ensuring high-quality clinical data delivery in compliance with regulatory requirements, SOPs, and study timelines.

Key Skills & Experience

• 8+ years of End-to-end Clinical Data Management experience from protocol review, CRF/eCRF design through database lock.
• Strong experience in EDC systems: Medidata RAVE and Oracle Clinical.
• Expertise in Data Review, Query Management, Query Trend Analysis, Protocol Deviation Review, and Data Quality oversight.
• Experience authoring and reviewing DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines, and related study documents.
• Knowledge of FDA/ICH-GCP guidelines, clinical drug development process, and regulatory submission requirements.
• Experience overseeing CRO/CDM vendors and managing study deliverables within timelines.
• Strong project management, metrics reporting, and stakeholder management skills.
• Experience supporting audits, inspections, and cross-functional study teams.
• Excellent communication, mentoring, and leadership abilities.
  
  

Key Responsibilities

• Support DML in study planning, execution, and project management activities.
• Draft EDC build timelines and perform database/edit check specification activities.
• Conduct UAT/testing for database, coding, site payment, and safety integrations.
• Create and maintain study documents and ensure filing in eTMF per study requirements.
• Coordinate data review activities and vendor deliverables.
• Support Data Quality Review meetings and provide study metrics.
• Manage post-production, migration, and database lock activities.
• Ensure high-quality, timely study delivery in compliance with SOPs and regulatory requirements.
• Provide training and mentoring to junior Clinical Data Management staff.
  
  

Location : Hyderabad, Office Based