In addition, the Senior Clinical Database Programmer can assist with the Database Primary or Technical Lead role on projects, and liaise with sponsors, Data Management Lead 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. 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.
- 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
- Support to build or integra

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