Executive IT (CTM)

ORGANISATIONAL OVERVIEW

JOB DETAILS

IT support: Clinical trial (Late phase clinical trials)

1. Monitor IT QA program as per GxP principles, and other applicable regulations for effective IT Compliance program implementation
2. Review of Validation & IT QA system specific documents and its approvals as applicable and support implementing IT compliance in Late phase
3. Ensure all Validated Computerized systems are in validated state at all times in department.
4. Ensure Validation plan is followed and adhered till the end of the project
5. Ensure deviations, Observations and issue during testing are documented, addressed and resolved.
6. Support process/business owner in coordinating with vendor representative for new user requirements or incidences.
7. IT related support within CTM department.
8. Software access right management and verification within CTM department as per requirement of applicable SOPs and other standard documents.
9. Contribute to the preparation of validation documents in collaboration with the cross functional teams
10. Software System enhancement/ upgradation related activities and required support as necessary from department.
11. Other responsibilities assigned by Supervisor/HOD/Management.

KEY DELIVERABLES

ALLIED RESPONSIBILITIES

EXPERIENCE

At least 5 years of experience in IT domain specifically in IT CSV and/ or GXP application. 

EDUCATIONAL QUALIFICATION

Any graduate having experience in software application and its validation, CSV, GXP

COMPETENCIES