About the Role:

The Clinical Programmer plays a key role in supporting clinical trials by developing and validating clinical data systems. Key duties include programming study databases, extracting data, and ensuring data integrity and regulatory compliance. This position will collaborate with data managers, statisticians, and researchers to support accurate data collection, analysis, and reporting, aiding in medical advancements and patient care. Strong programming and data management skills are essential for optimizing clinical processes.

Responsibilities

• :Develops programs to extract, integrate, and analyse data, generating specified outputs
• .Provides programming input throughout clinical study phases, from design to publication
• .Assists in setting up and maintaining software like Veeva for database programming and edit checks
• .Ensures data integrity by overseeing available data sources
• .Manages programming activities across studies, including external oversight when outsourced
• .Supports clinical data management tasks, such as eCRF and EDC system development
• .Contributes to quality standards and follows GCP practices
• .Reports to the Head of Clinical Operations and collaborates with the senior data manager

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Qualification

• s:Education: Bachelor's or Master’s in Computer Science, Bioinformatics, Statistics, or related fiel
• d.Technical Skills: Proficiency in SAS, R, Python, or SQL; experience with clinical databases (e.g., Oracle Clinical, Medidata Rave); familiarity with CDISC standards (SDTM, ADaM
• ).Experience: Clinical programming experience in pharmaceuticals or CROs, with knowledge of CDISC, SDTM, and ADaM standard
• s.Regulatory Knowledge: Understanding of GCP, FDA, EMA, and related clinical data guideline
• s.Soft Skills: Strong communication and analytical skills for engaging with project teams, gathering requirements, and translating them into data plans; ability to work collaboratively with teams in Biostatistics, Clinical Data Management, Pharmacovigilance, and other area

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