Job Description
Position Summary
The Senior Executive – Clinical Data Management is responsible for managing data management activities across multiple clinical research projects. The role involves overseeing data collection, validation, and reconciliation processes to ensure clinical trial data accuracy, completeness, and regulatory compliance.
Key Responsibilities
Project Data Management
Manage all data management activities for assigned clinical studies from study setup to database lock.
Ensure clinical trial data is accurate, complete, and consistent with study protocols and regulatory requirements.
Participate in project meetings and provide updates regarding data management progress and issues.
Process Documentation & Compliance
Prepare and review clinical data management documents including Data Management Plans, Data Edit Check Specifications, Data Transfer Agreements, Reconciliation Plans, and CRF Completion Guidelines.
Ensure compliance with company procedural documents, ICH-GCP guidelines, and local regulatory requirements.
Maintain all data management documentation in an audit-ready condition.
Data Review & Validation
Review clinical trial data for completeness, consistency, and validity.
Generate and resolve data queries with study sites and project teams.
Freeze or lock study databases once data review and validation activities are completed.
Data Reconciliation & Coding
Perform reconciliation activities including Serious Adverse Event (SAE) and third-party data reconciliation such as central laboratory data and electronic data files.
Coordinate with Medical Data Reviewers and Medical Monitors for coding of medical terminology.
Training & Collaboration
Coordinate training and system access for investigators, clinical research associates (CRAs), and study coordinators for EDC systems.
Participate in investigator meetings and training sessions for project teams.
Collaborate with cross-functional teams to support clinical trial execution.
Process Improvement
Identify process gaps and recommend improvements to enhance data management efficiency and quality.
Report quality metrics and timelines to project leads and other stakeholders.
Apply Details
Apply through the official careers portal of
Sun Pharmaceutical Industries Ltd.
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