Clinical Data Services Senior Analyst – Medical Monitoring

Location: Bengaluru, India
Experience: 5–8 Years
Job Code: AIOC-S01639556
Primary Skill: Clinical Data Services – Medical Monitoring
Function: Life Sciences R&D – Clinical Data Services
Work Schedule: Rotational Shifts

Job Overview

We are looking for an experienced Clinical Data Services Senior Analyst – Medical Monitoring to support clinical research and clinical trial operations within the Life Sciences R&D domain.

The role involves reviewing clinical study documentation, supporting clinical data validation, performing quality control of safety and efficacy deliverables, and ensuring compliance with study protocols and Standard Operating Procedures (SOPs). The successful candidate will collaborate with statistical programmers, study teams, offshore delivery teams, and client stakeholders to deliver accurate and high-quality clinical trial outputs.

The position also includes SAS programming support, validation, operational reporting, mentoring junior team members, and contributing to process improvement initiatives.

Key Responsibilities

Clinical Data Services & Study Support

• Review clinical study protocols, study setup documents, submission documents, and output specifications.

• Support clinical trial data processing and ensure the accuracy, consistency, and reliability of study deliverables.

• Review and validate protocol requirements in accordance with applicable SOPs and study specifications.

• Coordinate with study leads, statistical programmers, and client stakeholders to support study execution.

• Provide medical monitoring-related support for clinical trial oversight and safety requirements, as applicable.

Statistical Programming & Data Validation

• Develop and execute SAS programs and standard macros to generate SDTM datasets, tables, listings, figures, and study-specific outputs.

• Support the preparation and validation of standard and non-standard safety and efficacy deliverables.

• Apply clinical data and programming standards to improve consistency and efficiency across studies.

• Perform developer testing and validate datasets and outputs against approved specifications.

• Investigate programming and data discrepancies and implement corrective actions.

Quality Control & Compliance

• Perform quality control (QC) checks on clinical trial safety and efficacy deliverables.

• Ensure outputs comply with approved protocols, specifications, data standards, and project requirements.

• Maintain accurate programming, validation, and project documentation.

• Follow client and organizational SOPs, quality guidelines, and applicable clinical research requirements.

• Complete mandatory training within defined timelines and maintain readiness for quality reviews and audits.

Stakeholder & Project Coordination

• Act as a liaison between study teams, offshore delivery teams, onshore teams, and client stakeholders.

• Collaborate with Senior Statistical Programmers, study leads, programmers, and clinical research professionals.

• Communicate project updates, technical issues, risks, and dependencies to relevant stakeholders.

• Support timely delivery of study outputs and effective coordination across teams.

• Interact with supervisors, clients, and senior management as required.

Team Support & Knowledge Sharing

• Mentor and guide new hires on technical processes, documentation, and study requirements.

• Support onboarding and resolve technical or process-related queries.

• Conduct and evaluate Service Readiness Assessments for new resources.

• Assist with resource planning for ongoing and upcoming studies.

• Support Statistical Programming Managers and Service Delivery Leads with operational reporting and daily activities.

Process Improvement

• Analyze moderately complex problems and develop solutions using established methods and procedures.

• Identify opportunities to improve programming efficiency, quality, standardization, and delivery timelines.

• Support operational reporting, process improvement initiatives, and business excellence programs.

• Contribute to organizational task forces and continuous-improvement activities.

• Continuously enhance technical knowledge and clinical data services capabilities.

Required Qualifications & Experience

• 5–8 years of relevant experience in Clinical Data Services, clinical trial support, statistical programming, or a related Life Sciences R&D function.

• Experience in clinical trial data processing, validation, quality control, or study deliverables.

• Knowledge of clinical study protocols, study documentation, SOPs, and clinical research processes.

• Experience with SAS programming and clinical trial datasets or outputs, where required by the assigned role.

• Understanding of SDTM datasets and clinical data standards.

• Experience performing QC checks on safety and efficacy deliverables.

• Strong analytical, problem-solving, and troubleshooting skills.

• Excellent written and verbal communication skills.

• Strong documentation, coordination, and stakeholder-management abilities.

• Ability to work independently on routine assignments and manage moderately complex tasks.

• Willingness to work rotational shifts as required.

Preferred Technical Skills

• Clinical Data Services – Medical Monitoring

• Clinical Trial Data Review and Validation

• SAS Programming and Standard Macros

• SDTM and Clinical Data Standards

• Safety and Efficacy Deliverables

• Tables, Listings, and Figures (TLFs)

• Quality Control and Developer Testing

• Clinical Study Protocol Review

• SOP Compliance and Documentation

• Data Quality and Validation

• Project Coordination and Operational Reporting

• Resource Readiness and Knowledge Transfer

Key Competencies

• Analytical Thinking and Problem Solving

• Attention to Detail

• Quality and Compliance Orientation

• Technical Troubleshooting

• Written and Verbal Communication

• Cross-Functional Collaboration

• Independent Task Management

• Mentoring and Knowledge Sharing

• Time Management and Prioritization

• Continuous Improvement

Performance Expectations

The successful candidate will be responsible for accurate and timely completion of clinical data services deliverables, compliance with study protocols and SOPs, quality of programming and validation outputs, effective stakeholder coordination, and contribution to team performance and continuous improvement.

Ideal Candidate Profile

The ideal candidate has strong analytical skills, experience with clinical trial deliverables, and an understanding of clinical data standards and quality processes. They should be comfortable working with study teams and statistical programmers, supporting SAS-based deliverables where required, mentoring junior colleagues, and meeting deadlines in a rotational-shift environment.

Recruitment Note: Assess candidates for SAS programming, SDTM, and safety/efficacy output experience alongside medical monitoring knowledge. The exact technical requirements may vary depending on the assigned project.