Data Coordinator

Sun Pharma; Gurugram District; On-site; INR 400,000 - 680,000; Full time

Job summary

Sun Pharma is seeking a Data Coordinator for the MACR unit to support start-up documents, eCRF guidelines, DMP, SAE reconciliation, and data entry processes within clinical trials. The role emphasizes accurate data handling and adherence to regulatory standards.

Key duties include screen design UAT, edit checks UAT, discrepancy management, URS review support for IWRS, and ensuring timely SAE reconciliation and database lock activities. A strong background in Pharma CDM is essential.

Qualifications

• Pharmacy/Science degree required; post-graduate preferred.
• Minimum 3 years of experience in clinical data management in Pharma/CRO settings.
• Experience in creating data management documents, validation plans, screen UAT, edit checks UAT, and data query management.

Responsibilities

• Prepare and review start-up documents (eCRF completion guidelines, DMP, SAE reconciliation plan, clinical coding plan).
• Prepare edit specification document (ESD), test plan and data entry guideline.
• Screen design UAT.
• Edit checks UAT in CDMS as per ESD.
• Discrepancy management.
• Support Data Manager in URS review for IWRS.

Skills

Clinical data management

Data management documents

Validation plan

Screen UAT

Edit checks UAT

Query management

Education

Pharmacy/Science Graduate

Pharmacy/Science Post-Graduate

Job description

Job Title:

Data Coordinator

Business Unit:

MACR

Job Grade

G11 B

Location :

Sun House, Mumbai

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:

JOB DESCRIPTION (Data Coordinator): CRONOS

• 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
• Screen design UAT.
• 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 3 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.

1. Data Management Plan: list of activities in clinical trial
2. Check if designing is as per the Rules designed by programmer
3. 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.
4. 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).