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Programmer Analyst

Fortrea
Fortrea
2-5 years
Not Disclosed
Bangalore, Remote
10 April 6, 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

Programmer Analyst | Full-Time | Bangalore, India (Remote)
Experience Required: 2–5 years

Job Description:
We are seeking a skilled Programmer Analyst to support clinical data programming, database development, and data transformation activities for global clinical trials. This role focuses on designing study databases, managing data workflows, and generating standardized datasets (SDTM) in compliance with regulatory and industry standards. The ideal candidate will have strong expertise in clinical data systems, programming, and data validation processes.

Key Responsibilities:

Clinical Database Design & Setup

  • Design and set up clinical study databases in Clinical Data Management Systems (CDMS) based on protocol requirements.

  • Configure validation checks, derivations, and trial-specific edit checks, ensuring database readiness.

  • Review and provide input on EDC requirements, protocols, flowcharts, and study documentation.

  • Perform database activation and ensure compliance with study and regulatory requirements.

Data Management & Transformation (DMW/CDW)

  • Set up and manage models in Data Management Workbench (DMW) and Clinical Data Warehouse (CDW).

  • Develop mapping specifications for metadata and clinical data from source systems to DMW/CDW.

  • Perform transformation updates and manage external data configurations.

  • Generate SDTM (Study Data Tabulation Model) datasets and ensure compliance with CDISC standards.

Programming & Validation

  • Develop and validate programs to ensure data accuracy and support reporting requirements.

  • Perform User Acceptance Testing (UAT) and document pass/fail scenarios.

  • Conduct quality control (QC) checks and resolve data discrepancies in collaboration with stakeholders.

  • Support creation of study deliverables such as annotated CRFs (aCRF), define.xml, and Study Data Reviewer’s Guide (SDRG).

Process Improvement & Collaboration

  • Collaborate with cross-functional teams to define timelines, resolve issues, and ensure smooth study execution.

  • Share best practices, trial learnings, and process improvements across teams.

  • Contribute to internal workshops, training sessions, and knowledge-sharing initiatives.

  • Support implementation and optimization of data management systems and processes.

Compliance & Documentation

  • Ensure adherence to SOPs, GCP, GDP, and Good Programming Practices (GPP).

  • Maintain and update system-related documentation and validation records.

  • Support change management activities and continuous improvement initiatives.

  • Maintain Trial Master File (TMF) documentation as per regulatory requirements.

Additional Responsibilities:

  • Perform post-production updates and database changes as required.

  • Support data mapping from Oracle Clinical to CDW aligned with SDTM domains.

  • Coordinate with biostatistics teams for final SDTM package generation and submission readiness.

Qualifications & Experience:

  • Bachelor’s degree in Computer Science, Life Sciences, Statistics, or related field.

  • 2–5 years of experience in clinical data programming, CDMS, or clinical data management.

  • Hands-on experience with DMW, CDW, Oracle Clinical, or similar clinical data systems.

  • Strong knowledge of CDISC standards, including SDTM datasets and metadata mapping.

  • Experience with UAT, QC processes, and database validation in clinical trials.

  • Familiarity with programming and scripting for data validation and transformation.

  • Strong analytical, problem-solving, and organizational skills.

  • Excellent communication and teamwork abilities.

Location: Bangalore, India (Remote Work Available)

Why Join Us:

  • Work on global clinical trials with advanced data systems and technologies.

  • Gain exposure to end-to-end clinical data lifecycle, from database setup to submission.

  • Collaborate with multidisciplinary teams including clinical, data science, and biostatistics experts.

  • Access continuous learning opportunities and career growth in clinical data programming.