Data Co-ordinator

Sun Pharmaceutical Industries, Inc.; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Mumbai seeks a seasoned professional for the Clinical Data Management domain. The role focuses on start-up document preparation, data management plan creation, and SAE reconciliation, with emphasis on data integrity and regulatory readiness.

Candidate should have 5+ years in clinical data management within Pharma/CRO sectors, with experience in ESD, UAT, data queries, and master data management. This position offers growth within a global pharma environment.

Qualifications

• Minimum 5 years of experience in clinical data management.
• Experience in development of data management documents and validation plans.
• Experience in data cleaning and clinical data query management.

Responsibilities

• Preparation & Review of start-up Documents: eCRF completion Guidelines, DMP, SAE reconciliation plan, Clinical Coding Plan
• Preparation of Edit specification document (ESD), Test Plan and Data Entry Guideline
• Edit checks UAT in CDMS as per ESD
• Discrepancy Management
• Support Data Manager in URS review for IWRS
• Ensure timely completion of SAE reconciliation activities
• Ensure timely completion of closeout activities including database lock
• Preparation and update of Master Data Management File to ensure its completeness
• Preparation & Review of Data Management Report

Skills

Clinical Data Management

Data Management Documents

Validation Plan

UAT

Query Management

Education

Pharmacy/Science Graduate

Pharmacy/Post-Graduate

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Business Unit:

MACR

Location :

At Sun Pharma, we commit to helping you“Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Summary:

• Preparation & Review of start-up Documents: eCRF completion Guidelines, DMP, SAE reconciliation plan, Clinical Coding Plan
• Preparation of Edit specification document (ESD), Test Plan and Data Entry Guideline
• Edit checks UAT in CDMS as per ESD
• Discrepancy Management
• Support Data Manager in URS review for IWRS
• Ensure timely completion of SAE reconciliation activities
• Ensure timely completion of closeout activities including database lock
• Preparation and update of Master Data Management File to ensure its completeness
• Preparation & Review of Data Management Report

Job Requirements

Educational Qualification

Preferable: Pharmacy / Science Post-Graduate

Minimum requirement: Pharmacy / Science Graduate

Experience

Above 5 Years

Key Skills :

At least 5 years of experience in the clinical data management domain in Pharma/CRO industry. Experience in, development of data management documents, development of validation plan, screen UAT, edit check UAT, clinical data query management etc.

• Data Management Plan: list of activities in clinical trial
• Check if designing is as per the Rules designed by programmer
• Data cleaning and ensure error free data is entered example: age criteria is 18-65 but someone entered 74 years then system has to file a query and data coordinator would check if the query is filed correctly and raise with the concerned who put 74.
• Master data management: filing process basis index as its subjected to audits and inspections. Do QC of eTMF (Trial Master File)

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).