Data Coordinator
Job Details
Company: Sun Pharmaceutical Industries Ltd.
Business Unit: MACR
Location: Sun House, Mumbai
Date Posted: August 20, 2026
Experience: Above 5 years
Industry: Pharmaceutical / CRO
Function: Clinical Data Management
Role Overview
The Data Coordinator will support clinical data management activities across clinical trials, with responsibility for study start-up documentation, data management systems, user acceptance testing, discrepancy management, data reconciliation, database lock, closeout activities, and master data management.
The role requires close collaboration with Data Managers, programmers, clinical teams, and other stakeholders to ensure clinical trial data is accurate, complete, consistent, and inspection-ready.
Key Responsibilities
Clinical Trial Start-Up Activities
Prepare and review clinical trial start-up documents.
Develop and review:
eCRF Completion Guidelines
Data Management Plan (DMP)
SAE Reconciliation Plan
Clinical Coding Plan
Prepare Edit Specification Documents (ESD).
Prepare Test Plans.
Prepare Data Entry Guidelines.
Ensure data management documentation is complete and aligned with study requirements.
Edit Check and System Validation
Support screen design User Acceptance Testing (UAT).
Perform edit check UAT in the Clinical Data Management System (CDMS).
Verify that system edit checks are implemented according to approved Edit Specification Documents.
Review system functionality and identify discrepancies or issues during testing.
Coordinate with programmers and relevant stakeholders to resolve identified issues.
Discrepancy and Query Management
Manage clinical data discrepancies and queries.
Review data for completeness, accuracy, and consistency.
Ensure appropriate queries are generated for data inconsistencies.
Monitor resolution of clinical data queries.
Escalate unresolved or significant data issues to the appropriate stakeholders.
Example of Data Validation
For example, if the protocol specifies an eligible age range of 18–65 years and a subject is entered as 74 years old:
The system should identify the discrepancy through an appropriate edit check.
A query should be generated to clarify the data.
The Data Coordinator reviews whether the query was appropriately generated.
The issue is followed up with the relevant site or stakeholder.
The discrepancy is resolved and documented appropriately.
Data Management Plan
Support development and implementation of the Data Management Plan.
Maintain an overview of clinical data management activities throughout the study.
Ensure planned data management activities are completed according to timelines.
Track data cleaning and database readiness activities.
Support the Data Manager in monitoring overall data quality.
SAE Reconciliation
Support preparation and implementation of the SAE reconciliation plan.
Perform or coordinate SAE reconciliation activities.
Ensure SAE reconciliation activities are completed within agreed timelines.
Identify discrepancies between safety and clinical databases.
Coordinate resolution of SAE-related discrepancies with relevant stakeholders.
IWRS Support
Support the Data Manager in reviewing User Requirement Specifications (URS) for Interactive Web Response Systems (IWRS).
Review data requirements and system specifications.
Provide input from a clinical data management perspective.
Support testing and validation activities where required.
Database Lock and Closeout
Support timely completion of clinical database closeout activities.
Participate in database lock activities.
Ensure outstanding data discrepancies and queries are appropriately resolved before database lock.
Support final data cleaning activities.
Ensure required documentation is complete and maintained according to study requirements.
Master Data Management
Prepare and maintain the Master Data Management File.
Ensure the file remains complete, accurate, and up to date.
Maintain appropriate documentation and filing structures.
Ensure records are organized according to established indexing requirements.
Support audit and inspection readiness.
Data Management Reporting
Prepare and review Data Management Reports.
Track the status of data management activities.
Document key data quality and operational metrics.
Identify outstanding activities, discrepancies, and potential risks.
Communicate relevant issues to the Data Manager and study team.
eTMF and Documentation Quality
Support appropriate filing of clinical trial documentation.
Maintain documentation according to established indexing and filing processes.
Perform Quality Control (QC) of the electronic Trial Master File (eTMF), where applicable.
Ensure documentation is complete, accurate, traceable, and inspection-ready.
Support audit and regulatory inspection requirements.
Key Clinical Data Management Activities
The role involves supporting activities such as:
Data Management Plan development
eCRF completion guideline development
Clinical coding plan development
SAE reconciliation
Edit specification development
Test plan development
Data entry guideline development
Screen design UAT
Edit check UAT
Clinical data query management
Data cleaning
Database closeout
Database lock
Master data management
Data management reporting
eTMF QC
Audit and inspection readiness
Required Educational Qualification
Minimum: Bachelor’s degree in Pharmacy or Science.
Preferred: Postgraduate degree in Pharmacy or Science.
Required Experience
Minimum: More than 5 years of experience.
At least 5 years of experience in clinical data management.
Experience in the pharmaceutical or CRO industry.
Experience with clinical trial data management processes.
Experience developing clinical data management documents.
Experience with validation plans and testing activities.
Experience with screen design UAT.
Experience with edit check UAT.
Experience with clinical data query management.
Experience with data cleaning and reconciliation activities.
Key Skills
Clinical Data Management
Data Management Plans
Clinical Trial Data
eCRF
CDMS
Edit Specifications
Edit Checks
UAT
Data Validation
Data Cleaning
Query Management
SAE Reconciliation
Clinical Coding
IWRS
Database Lock
Database Closeout
Master Data Management
Data Management Reporting
eTMF
Quality Control
Audit Readiness
Inspection Readiness
Role Expectations
The Data Coordinator is expected to ensure that clinical trial data management activities are executed accurately and within agreed timelines.
The role requires strong attention to detail, an understanding of clinical data management processes, effective coordination with cross-functional teams, and the ability to identify and resolve data discrepancies.
The position also requires maintaining accurate documentation and ensuring that clinical trial records are organized and inspection-ready.
Ideal Candidate Profile
The ideal candidate is a clinical data management professional with 5+ years of experience in the pharmaceutical or CRO industry, preferably with a Pharmacy or Science background.
The candidate should have hands-on experience in clinical data management documentation, UAT, edit checks, query management, data cleaning, SAE reconciliation, database lock, and eTMF/document quality activities.
Strong attention to detail, coordination skills, knowledge of clinical trial processes, and an understanding of data quality requirements are important for success in this role.
Company Culture
Sun Pharma emphasizes continuous development, ownership, collaboration, innovation, teamwork, accountability, and professional growth. The organization encourages employees to take charge of their careers while contributing to high-quality clinical development and research activities.
Disclaimer
This job description describes the general nature and level of work expected for the position. It is not intended to be a comprehensive list of all responsibilities, duties, or qualifications. Sun Pharma may modify responsibilities or assign comparable duties based on business requirements and the employee’s experience and background.
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