Clinical Database Programmer

Role & responsibilities

• Review functional requirement specification documents created by project study teams.
• Develop, program, validate and maintain eCRFs and additional modules Create and maintain library of standard CDASH compliant CRFs
• Ensure that appropriate edit check specifications and quality control checks are implemented as per clinical investigation protocol
• Completes mid study database updates (post production changes) as specified per Change Request documents and procedures
• Ensure accuracy and validation of clinical database development Provide annotated and blank CRF to business
• Assist in updating processes to any change in regulation
• Responsible for SOP preparation and update
• Perform User and Site Administration to include site set up and assignment of roles, permissions, and eLearning requirements
• Partner with CoE Data Management team members to prioritize deliverables
• Process and reviews database accounts regularly to ensure integrity of database access and security
• Liaise with EDC product support team for trouble shooting any issue identified during study build or execution
• Maintain all required Configuration Specifications and Quality Control documents as required
• Perform database testing
• Maintaining database design documentation audit-ready

Preferred candidate profile

• BE/BTech, ME/MTech, MS in Biotechnology / Bioinformatics / Pharmacy/ Computer Science or related domain
• Minimum industrial experience of about 3 years in data management for clinical trial
• Expertise in database designing and programming rules & edit checks. Minimum 1-2 years experience in Data Management. Min 1 year experience in Database design.
• Knowledge of Oncology, Cardiology, Hematology, Neurology therapeutic area is desirable.
• Min 1yr Database design experience on Zelta platform (previously Merative Clinical Development and formerly IBM Clinical Development) with Basic Designer certificate. Certificate on additional modules like Endpoint Adjudication, Data Migrator, Smart Report. Inventory/Dispensing is highly desirable. Clinical database design experience in Veeva EDC is desirable
• EDC expertise is highly preferrable
• Good understanding of data visualization tool such as PowerBI
• Experience with CDASH and SDTM standards
• Experience in Medical devices studies is an advantage