Programmer Analyst I
New
IndiaFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 4–7 years
- Required Skills
- GCPTableau
Requirements
- 4–7 years of relevant experience in clinical data management, database programming, or clinical systems support.
- At least 2 years of hands-on experience in protocol interpretation and clinical study build activities.
- Strong understanding of clinical trial processes, data management, and biometrics principles.
- Experience working with EDC tools such as Medidata Rave and/or Veeva Systems.
- Familiarity with clinical programming deliverables such as edit checks, listings, and database design documentation.
- Knowledge of CDISC standards and regulatory expectations in clinical research environments.
- Experience with data visualization tools such as Spotfire or Tableau is a plus.
- Strong analytical, problem-solving, and attention-to-detail skills.
- Ability to manage multiple projects independently and meet tight deadlines.
- Excellent communication, teamwork, and stakeholder coordination abilities.
- Bachelor’s degree in Life Sciences, Health Sciences, IT, or related field preferred.
Responsibilities
- Perform independent programming activities across multiple clinical studies using EDC systems such as Medidata Rave or Veeva.
- Interpret clinical study protocols and data management specifications to design and build clinical databases and edit checks.
- Develop and validate database structures, datasets, and programming specifications aligned with CDISC and client standards.
- Create and maintain submission deliverables including annotated CRFs, Define XML/PDFs, and Reviewer’s Guides.
- Build and support data quality checks, listings, protocol deviation reports, and post-production database enhancements.
- Develop visual analytics dashboards using tools such as Spotfire or Tableau to support study insights.
- Ensure compliance with GCP guidelines, SOPs, and regulatory requirements in all programming activities.
- Perform database reconciliation, quality checks, and validation of clinical programming outputs.
- Collaborate with cross-functional teams and communicate data issues to data management stakeholders.
- Support training and mentoring of junior team members on EDC tools and programming practices.
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