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.




- Monitor project resourcing and identify changes in scope.
- Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first
- time quality.
- Interact with Sponsors and Data Management Leaders as the key contact regarding programming related issues.
- Provide technical support and advice to the internal team.- Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required).
- Support Projects & Technologies
- Assist in providing technical solutions to internal or external/client enquiries.
- Support to build or integrate systems within the GDO Area. Execute other programming languages and processes within the GDO area. (e.g. Clinical Trial Management System, Safety Systems, Coding Systems).
- Ensure adherence to service levels agreements regarding the turnaround time from the point when specifications are finalized.
- Documentation
- Maintain all s

📌 Principal Clinical Database Programmer (Hyderabad)
🏢 Parexel
📍 Hyderabad