YOUR CONTRIBUTION
Become part of our Global Clinical Data Management team at Merz Therapeutics and support the oversight of clinical IT systems and data quality activities within a regulated GCP environment. This position is offered as an internship with a duration of 6 months, providing hands-on experience in clinical IT systems and data management within a global pharmaceutical environment. In this role, you will contribute to the following tasks:
- Support oversight of clinical IT systems in a GCP-regulated environment
- Track system status and maintain IT system documentation
- Support implementation of regulatory requirements (e.g. GxP, GDPR, 21 CFR Part 11) with vendors
- Assist with system risk assessments, re-evaluations, and QA checklists
- Support change management activities (updates, change control, decommissioning)
- Support validation and qualification of data transfers and system interfaces
- Assist with sponsor data quality oversight (data review, trend analysis, outlier detection)
- Support filing, transfer, and archiving of essential IT and data oversight documents