04 ago - Cusano Milanino
Experteer Italy
Overview
In this role you will manage and ensure the integrity of clinical data within PSI’s global trial operations. You will collaborate with cross-functional teams to design and validate data capture, lead data quality initiatives, and support regulatory-ready databases. You help drive timely database locks and maintain data management documents, contributing to PSI’s mission of high-quality, timely clinical services. This is an opportunity to shape data workflows in a diverse, inclusive environment at a globally active CRO.
Benefits
- Track database set-up, testing, maintenance and data entry
- Communicate with clients, project teams and vendors on data management matters
- Review study documents, design and develop project specific guidelines and instructions
- Design eCRF, Data Management and Data Validation Plans and test EDC databases
- Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
- Code medical data
- Track and report metrics leading to database lock
- Coordinate the processing, dispatch and archiving of CRFs/queries
- Maintain Clinical Data Management working files
- Perform database QC checks, prepare and attend audits
- Train site staff and project teams on CRF completion and data management topics
Responsibilities
- Demonstrated experience of managing clinical or medical data
- Full working proficiency in English
- Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)
- Proficiency in MS Office applications
- Organisational and time management skills
- Ability to work independently and multi-task
Qualifications
- Base salary range 34,000-52,000 gross annual salary
- Premio
- Incentive plans
- Other benefits may apply
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