Data Coordinator

About Sun Pharma

Sun Pharmaceutical Industries Ltd. is dedicated to fostering an environment where employees can grow continuously, take ownership of their careers, and thrive as part of a supportive community.

Job Overview

The Data Coordinator plays a vital role in clinical data management within pharmaceutical and CRO settings, focusing on preparing and reviewing essential documents, managing data discrepancies, supporting data management systems, and ensuring alignment with clinical trial requirements.

Primary Responsibilities

• Create and review start-up documents including eCRF completion guidelines, Data Management Plan (DMP), SAE reconciliation plan, and Clinical Coding Plan.
• Develop Edit Specification Documents (ESD), Test Plans, and Data Entry Guidelines relevant to clinical data handling.
• Participate in User Acceptance Testing (UAT) for screen designs and edit checks within Clinical Data Management Systems (CDMS) according to ESD.
• Manage discrepancies arising from clinical data to ensure accuracy and compliance.
• Support Data Manager in reviewing User Requirement Specifications (URS) for Interactive Web Response Systems (IWRS).
• Ensure timely execution of Serious Adverse Event (SAE) reconciliation and database closeout activities.
• Prepare and maintain the Master Data Management File, ensuring completeness and audit readiness.
• Develop and update Data Management Reports reflecting clinical data management processes and outcomes.

Qualifications and Requirements

• Minimum of a graduate degree in Pharmacy or Science; postgraduate qualifications preferred.
• Over 5 years of experience in clinical data management within pharmaceutical or CRO environments.
• Proven expertise in drafting clinical data management documents, validation plans, and conducting UATs.
• Strong knowledge of data cleaning principles and discrepancy management, including query evaluation and resolution based on clinical criteria.
• Experience with Master Data Management, trial master file quality checks, and compliance with audit and inspection standards.

Additional Information

Sun Pharma values employee success and well-being, offering benefits and opportunities for both personal and professional development. The job description outlines typical tasks and expectations but does not limit management's right to modify duties aligned with business needs.