Database Designer

Sun Pharma; Gurugram District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sun Pharma is seeking a Data Base Designer for the MACR unit in Mumbai. The role involves CRF design for regulatory submissions, CDMS database design, and detailed data management documentation. You will work with regulatory teams to ensure accurate data capture and compliant data handling.

The ideal candidate has at least 5 years in clinical data management within Pharma/CRO environments and strong experience with EDC tools like Octalsoft, CRONOS, Medidata Rave, Inform, or Oracle.

Qualifications

• Minimum of 5 years of experience in clinical data management in Pharma/CRO.
• Experience in database development/clinical programming is required.
• EDC tools experience is a must.

Responsibilities

• CRF Designing for Regulatory submission.
• CRF Annotation activity.
• Database design in CDMS.
• Preparation/review data entry guideline documents and eCRF completion guidelines.
• Creation and assignment of investigator & Site in CDMS.
• Review of site-specific lab ranges and creation of labs in CDMS.
• Preparation/review of edit specification documents and Test Plans.
• Validation programming/edit check programming and rule designing in CDMS.
• Data extraction from the Clinical Data Management system.
• Support Data Manager in URS review for IWRS.
• Prepare and update Master Data Management File to ensure completeness.

Skills

Clinical data management

Education

Pharmacy/Science/Computer science Graduate

Tools

Octalsoft

CRONOS

Medidata Rave

Inform

Oracle

Job description

Job Title:

Data Base Designer

Business Unit:

MACR

Grade:

G12A

Location:

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 DESCRIPTION (Database Designer):

• CRF Designing for Regulatory submission
• CRF Annotation activity
• Database design in CDMS
• Preparation / review data entry guideline document, eCRF completion guidelines
• Creation and assignment of investigator & Site in CDMS
• Review of site-specific lab ranges
• Creation and assignment of labs in the CDMS
• Preparation /review edit specification document and Test Plan
• Validation procedure programming/ Edit check programming/Rule designing in CDMS
• Review of edit specification document and Test Plan.
• Data extraction from Clinical Data Management system
• Support Data Manager in URS review for IWRS
• Preparation and update of Master Data Management File to ensure its completeness

Job Requirements

Educational Qualification

Preferable: Pharmacy / Science /Computer science Post-Graduate

Minimum requirement: Pharmacy / Science/ Computer science Graduate

Experience

At least 5 years of experience in the clinical data management domain in Pharma/CRO industry with experience in database development/clinical programming

Skillsrequiredinclude:

RELATED EXPERIENCE REQUIREMENT

:. Experience in EDC tools like Octalsoft, CRONOS, Medidata Rave, Inform or Oracle etc is a must

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’screate a brighter future together!

Disclaimer:

The preceding job description has been designed toindicatethe general nature and level of work performed by employee within this classification. It is not designed tocontainor be interpreted as a comprehensive inventory of all duties, responsibilities, and qualificationsrequired ofemployees as assigned to this job. Nothinghereinshallpreclude the employer from changing these duties from time to time and assigning comparable duties or other dutiescommensuratewith the experience and background of incumbent(s).