Lead Data Manager for Clinical Trials
PSI CRO · Buenos Aires
Job description
About the role
The Lead Data Manager will oversee all data management activities for large, complex clinical studies, ensuring high‑quality data collection, cleaning, and reporting. This role serves as the primary communication hub between project teams, clients, and vendors.
Key responsibilities
- Coordinate EDC development, data entry, validation, reconciliation, and database lock for clinical projects.
- Develop and review data management plans, validation specifications, and CRF design guidelines.
- Manage non‑CRF electronic data handling, coding of medical data, and SAE reconciliation.
- Liaise with document centers for TMF/eTMF maintenance and support internal and external audits.
Required profile
- University degree or equivalent experience.
- Minimum 3 years of full‑scope data management in international EDC studies.
- At least 2 years using CDM/EDC systems (Medidata Rave or Oracle Inform preferred).
- Full professional proficiency in English and strong organizational/managerial skills.
Required skills
- Medidata Rave
- Oracle Inform
- EDC systems
- Data validation and query management
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Published 1 day ago
Expires 1 month from now
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PSI CRO
Buenos Aires