Sr. Executive – Clinical Data Management
Company: Sun Pharmaceutical Industries Ltd
Location: Gurgaon – R&D, India
Function: Clinical Data Management
Job Type: Full-Time
Geographic Scope: Global Clinical Studies
Experience Required: Minimum 6 Years in Clinical Data Management
Education: Bachelor’s Degree in Life Sciences, Nursing, Computer Science, or Related Discipline
Posted On: February 27, 2026
About the Company
Sun Pharmaceutical Industries Ltd is one of the world’s leading specialty generic pharmaceutical companies, with a strong global footprint across regulated and emerging markets. The organization drives innovation in research and development while maintaining strict adherence to ICH-GCP, regulatory frameworks, and global data integrity standards.
Role Overview
The Sr. Executive – Clinical Data Management will be responsible for managing end-to-end data management activities across global clinical trials. The role involves oversight of study start-up, database setup, data cleaning, reconciliation, and database lock in alignment with SOPs, ICH-GCP guidelines, and applicable regulatory standards.
This position requires strong expertise in electronic data capture (EDC) systems, global clinical study coordination, and maintaining audit-ready documentation throughout the clinical trial lifecycle.
Key Responsibilities
Clinical Data Lifecycle Management
Manage all data management activities from study setup to database lock for assigned projects
Review, freeze, and lock clinical data ensuring accuracy, completeness, consistency, and validity
Generate and manage data queries in coordination with study sites and project teams
Maintain study documentation in audit-ready condition
Project Coordination & Stakeholder Engagement
Attend regular project meetings and provide status updates on data management deliverables
Report quality metrics, timelines, and performance indicators to project leads and stakeholders
Support investigator meetings and PM/CRA training sessions when required
Documentation & Compliance
Prepare and review key data management documents including:
Data Management Plan (DMP)
Data Edit Check Specifications
User Acceptance Testing (UAT) documents
Data Transfer Agreements (DTA)
Reconciliation Plans
CRF Completion Guidelines
Coding Guidelines
Ensure compliance with ICH-GCP, Sun procedural documents, and local regulatory requirements
EDC & Training Oversight
Coordinate EDC access and training for investigators, study coordinators, CRAs, and data entry personnel
Oversee data cleaning and reporting processes as per study-specific parameters
Data Reconciliation & Coding
Perform reconciliation of SAE/AE data, Electronic Data Files (EDF), central lab data, IVR systems, and third-party datasets against the clinical database
Coordinate with Medical Data Reviewers and Medical Monitors for medical coding activities
Track reconciliation issues to resolution
Process Improvement & Innovation
Identify operational gaps and recommend data management process improvements
Participate in internal and external training programs to enhance domain expertise
Required Skills & Competencies
Minimum 6 years of hands-on experience in Clinical Data Management
Strong working knowledge of clinical data capture tools (EDC systems)
Experience in managing global clinical trials preferred
Strong understanding of clinical database lifecycle management
Knowledge of medical coding processes and reconciliation workflows
Ability to manage timelines and deliverables across multiple studies
Strong analytical, documentation, and communication skills
Work Conditions
Full-time role
Presence at work required
Infrequent travel
Why Join Sun Pharma
At Sun Pharmaceutical Industries Ltd, clinical data professionals work in a globally integrated R&D ecosystem focused on quality, compliance, and innovation. The organization offers opportunities to contribute to complex global trials while strengthening expertise in regulatory-grade data governance and database management.
Disclaimer
This job description outlines the general scope and responsibilities of the role. Duties may be modified or expanded in accordance with business needs and organizational requirements.
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