The Principal Clinical Database Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. In addition, the Principal Clinical Database Programmer can fill the Database Primary (late phase) or Technical Lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as required. General areas of responsibility also include eCRF design, edit check programming and integration of third-party systems with the EDC databases. Further, the Principal Clinical Database Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets. All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
Key Accountabilities
Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems
- Lead and supervise and/or create,
implement and execute procedures to build and maintain database set-up for paper-based and/or web-based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.
- Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
- Accountable for first time quality on all deliverables.
- Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines.
- Provide input into and negotiate database setup timelines. Ensure that timelines are adhered to.
- Coordinate and lead a programming team to successful completion of a study within given timelines and budget.
- Actively assume activities on a project as required.
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📌 Principal Clinical Database Programmer (Hyderabad)
🏢 JobsInSAS.com
📍 Hyderabad
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