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Sr. Executive -Clinical Data Management

Sun Pharma
Sun Pharma
6 years
Not Disclosed
Gurgaon, India
10 Feb. 27, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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