Principal Study Build Programmer

Overview

Principal Study Build Programmer responsible for programming and testing clinical trial data collection databases and delivering standardized data collection methods for global studies.

What you'll do

• Develop and test program/trial data collection systems using data standards library.
• Deliver data collection systems aligned with study objectives.
• Provide study-level insights including DMP, project plan, database, and observed datasets.
• Support submission, inspection, and regulatory response activities.
• Increase speed, accuracy, and consistency of system solutions development.
• Partner with Clinical Data Management Associate to deliver study database before first patient visit.
• Improve re-usability of forms and edits and reduce post-production change control steps.

What you'll need

• 7 years of database programming and system validation experience in clinical/pharma/biotech/CRO or regulatory agency sectors.
• Bachelor’s degree in computer science, engineering, medical field, informatics, life sciences, health information administration, statistics, information technology, nursing, or pharmacy.
• In-depth understanding of data technology, data flow, and data standards.
• Ability to apply internal/external/regulatory requirements/expectations (including MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, privacy knowledge).
• Utilize therapeutic knowledge and deep understanding of technology used to collect clinical trial data.
• Collaborate with clinical data management/data associates and other stakeholders.

Details

• Job located in Bangalore, India.
• Domestic and international travel may be required.