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Programmer Analyst

Fortrea
Fortrea
2+ years
Not Disclosed
Bangalore, India
10 April 22, 2026
Job Description
Job Type: Full Time Remote Education: B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology) 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

Job Title:

Clinical Data Programmer (DMW / SDTM)


Job Overview:

The Clinical Data Programmer is responsible for designing, setting up, and managing clinical trial databases, performing data transformations, and generating SDTM deliverables. The role involves working with systems like CDMS, DMW, and CDW, ensuring data accuracy, regulatory compliance, and timely delivery of high-quality clinical datasets.


Key Responsibilities:

Database Design & Set-Up:

  • Design and set up clinical trial databases based on protocol requirements
  • Create and configure trials in CDMS (Clinical Data Management System)
  • Apply validation and derivation checks; build study-specific checks
  • Perform database activation after stakeholder approval
  • Handle database-related issues as programming point of contact

Data Management Workbench (DMW) Activities:

  • Set up trials and models in DMW
  • Create mapping specifications and external data specifications
  • Configure file watchers for external data models
  • Perform transformation updates and model installations

Data Mapping & SDTM Deliverables:

  • Map metadata and clinical data from source systems to DMW/CDW
  • Perform SDTM staging and transformation (DMW SDTM Raw)
  • Load and validate data across all models
  • Transform data from CDMS to Statistical Computing Environment (SCE)
  • Generate SDTM datasets and deliverables

Programming, Validation & Testing:

  • Design and program validation checks for data accuracy
  • Perform User Acceptance Testing (UAT) for databases and SDTM outputs
  • Document pass/fail scenarios and maintain testing records
  • Conduct QC checks and resolve issues in coordination with leads

Documentation & Compliance:

  • Maintain system and study-related documentation
  • Create and update:
    • aCRF (Annotated Case Report Forms)
    • define.xml
    • SDRG (Study Data Reviewer’s Guide)
  • Ensure compliance with:
    • SOPs
    • GCP, GDP, and GPP guidelines
  • Maintain Trial Master File (TMF) documentation

Collaboration & Communication:

  • Collaborate with trial teams on timelines and deliverables
  • Provide inputs to:
    • EDC requirements
    • Project plans and blinding plans
  • Share best practices and trial learnings within the team
  • Participate in workshops, meetings, and knowledge-sharing sessions

Process Improvement & Support:

  • Support implementation of DaMaSys (Data Management Systems & Standards) processes
  • Identify and implement process improvements
  • Assist in change management and optimization initiatives
  • Support internal training and guide team members

Additional Responsibilities:

  • Perform post-production updates and database changes
  • Activate databases in Oracle Clinical (OC)
  • Map data from OC to CDW ensuring SDTM compliance
  • Finalize SDTM packages in coordination with Biostatistics

Skills & Competencies:

  • Strong understanding of clinical data management systems
  • Knowledge of SDTM standards and clinical data mapping
  • Attention to detail and strong analytical skills
  • Good programming and validation expertise
  • Strong documentation and compliance awareness
  • Effective communication and teamwork skills

Technical Knowledge:

  • Experience with:
    • CDMS, DMW, CDW
    • Oracle Clinical (OC)
    • EDC systems
  • Understanding of:
    • SDTM domains and standards
    • Data transformation and validation processes

General Responsibilities:

  • Ensure compliance with SOPs and regulatory standards
  • Provide regular status updates to management
  • Promote collaboration and knowledge sharing
  • Contribute to a positive and productive team environment

Work Environment:

  • Office-based or remote setup (depending on organization)
  • Requires extensive computer-based work