IT Configuration Specialist - Medidata CTMS\\SSU & eTMF
BengaluruFull-time3–8 yrsPosted over a month ago
Mid-level pharma role at Merck KGaA (MilliporeSigma / EMD) in Bengaluru. Needs 3+ years and a B.Tech, B.E. or B.Sc.
About the role
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
What you'll do
- Provide required evidence, documentation, and support during internal and external audits
- Update and maintain operational phase qualification documents, including TS, TRA, CS, FRS, Admin Guides, and related artifacts
- Review of Data Integrity, Backup, and Disaster Recovery (DR)
- Perform periodic reviews of data integrity controls, backup processes, and DR readiness for compliance and operational continuity
- Act as the final escalation point for high-impact or recurring issues from L1/L2 support teams
What you need
- Clinical data management
- Documentation
- GCP
- Clinical research
- Root cause analysis
- Communication
Good to have
- SOP writing