Job Title: Clinical Data Svs Sr Analyst

Location: Bengaluru
Experience: 5–8 Years
Education: Any Graduate
Shift: Rotational Shifts

Job Summary:
The role is aligned with the Life Sciences R&D vertical and focuses on Clinical Data Services and Medical Monitoring. The position involves providing medical and clinical data expertise for clinical trial oversight, safety and efficacy deliverables, data validation, programming, quality control, and study execution.

Key Responsibilities:
• Analyze and resolve moderately complex clinical data and programming-related problems.
• Review protocols, study setup documents, submission documents, and output specifications.
• Perform QC checks for standard and non-standard safety and efficacy deliverables.
• Develop SAS programs and execute standard macros to generate SDTM-like datasets, SDTM datasets, tables, listings, figures, and trial-specific outputs.
• Perform developer testing and validate datasets and outputs according to defined standards.
• Apply clinical data and programming standards to improve efficiency and consistency across studies.
• Maintain project, validation, programming, and study documentation as per SOP requirements.
• Coordinate with study teams, offshore teams, onshore teams, and client stakeholders.
• Collaborate with Senior Statistical Programmers, study leads, and programmers for smooth study execution.
• Support medical monitoring, clinical trial oversight, and safety-related activities.
• Mentor new hires and support onboarding, technical queries, and process-related concerns.
• Support resource management, service readiness assessments, operational reporting, and daily study activities.
• Follow all applicable client and organizational SOPs, quality standards, and compliance requirements.
• Complete required training and continuously enhance technical and clinical data skills.

Key Skills:
• Clinical Data Services
• Medical Monitoring
• Clinical Trial Data Management
• Clinical Data Analysis
• Clinical Trial Support
• SAS Programming
• SAS Macros
• SDTM
• SDTM-like Datasets
• Clinical Data Validation
• Data Quality Control
• Clinical Data Standards
• Safety and Efficacy Data
• Protocol Review
• Statistical Programming
• Tables Listings Figures
• Quality Assurance
• SOP Compliance
• Study Management
• Clinical Research
• Life Sciences R&D
• Clinical Trial Oversight
• Data Validation
• Problem Solving
• Analytical Skills
• Stakeholder Management
• Client Coordination
• Technical Documentation
• Team Collaboration
• Mentoring