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Database Designer (Clinical Trials)

Sun Pharma
Sun Pharma
5 years
preferred by company
10 Jan. 28, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Database Designer – Clinical Trials

Company: Sun Pharmaceutical Industries Ltd.
Business Unit: Clinical Research & Development
Location: Mumbai, India (Remote / Work from Home)
Employment Type: Full-Time
Experience Required: Minimum 5 years
Posted Date: January 10, 2026


About Sun Pharma

Sun Pharmaceutical Industries Ltd. is a global specialty pharmaceutical company committed to advancing healthcare through innovation, quality, and patient-focused research. With a strong presence across regulated markets, Sun Pharma continues to invest in robust clinical development capabilities and cutting-edge data management systems to support high-quality clinical trials worldwide.

Sun Pharma fosters a collaborative, growth-driven work environment where professionals are empowered to take ownership, continuously learn, and contribute meaningfully to global clinical research programs.


Position Overview

The Database Designer (Clinical Trials) will play a critical role within the Clinical Data Management (CDM) function, responsible for designing, validating, and maintaining clinical trial databases to support regulatory submissions and data integrity. This role requires strong hands-on expertise in EDC/CDMS platforms, CRF design, edit check programming, and database validation within a pharmaceutical or CRO environment.

The position offers remote working flexibility and provides exposure to global clinical development programs.


Key Responsibilities

Clinical Database & CRF Design

  • Design and develop Case Report Forms (CRFs) in compliance with regulatory and study requirements

  • Perform CRF annotation activities aligned with CDISC and regulatory submission standards

  • Design and configure clinical trial databases within Clinical Data Management Systems (CDMS)

CDMS Configuration & Validation

  • Prepare and review Data Entry Guidelines and eCRF Completion Guidelines

  • Create, assign, and manage investigators and study sites within CDMS

  • Configure and review site-specific laboratory ranges

  • Create and assign laboratory data structures within CDMS

  • Prepare, review, and maintain Edit Specifications and Database Test Plans

  • Perform edit check programming, rule design, and validation programming in CDMS

Data Review & System Support

  • Conduct data extraction from Clinical Data Management Systems for review and reporting

  • Support Data Managers in User Requirement Specification (URS) reviews for IWRS integrations

  • Prepare, update, and maintain Master Data Management Files ensuring completeness and audit readiness


Required Qualifications

  • Postgraduate degree in Pharmacy, Life Sciences, Computer Science, or a related discipline

  • Formal training or certifications in Clinical Data Management or Clinical Systems preferred


Experience Requirements

  • Minimum 5 years of hands-on experience in Clinical Data Management within the Pharmaceutical or CRO industry

  • Proven experience in database design and development for clinical trials

  • Mandatory experience working with EDC/CDMS platforms such as Octalsoft, CRONOS, Medidata Rave, Inform, Oracle Clinical, or equivalent systems


Key Skills & Competencies

  • Strong understanding of clinical trial data standards and regulatory requirements

  • Expertise in CRF design, database build, edit checks, and validation processes

  • Familiarity with CDISC standards and regulatory submission expectations

  • Strong analytical, documentation, and problem-solving skills

  • Ability to work independently in a remote environment while collaborating with cross-functional global teams


Why Join Sun Pharma

Sun Pharma offers a dynamic and inclusive workplace where professionals can contribute to impactful clinical research while advancing their careers. Employees benefit from flexible work arrangements, continuous learning opportunities, and exposure to global clinical development programs.


Disclaimer

This job description outlines the general nature and level of responsibilities associated with this role and is not intended to be an exhaustive list. Sun Pharma reserves the right to modify responsibilities in line with business needs.


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