Senior Clinical Data Manager – Trials & Data Quality

Psi CRO; Milano; Ibrido; EUR 34.000 - 52.000; Tempo pieno

Descrizione del lavoro

PSI is seeking a detail‑oriented Clinical Data Manager to join our CRO team in Milano. You will manage clinical data, design CRFs and EDM plans, and ensure data quality across projects.

Responsibilities include database setup, validation, SAE reconciliation, data entry oversight, and interaction with clients and vendors. English proficiency and CRO data management experience required.

Competenze

• Demonstrated experience of managing clinical or medical data in a CRO is a must.
• 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.

Mansioni

• 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

Conoscenze

MS Office

Time management

Independent work

Multi-tasking

English

Formazione

Life Science degree

Pharmacy degree

Strumenti

Medidata Rave

Oracle InForm

Descrizione del lavoro

PSI is seeking a detail‑oriented Clinical Data Manager to join our CRO team in Milano. You will manage clinical data, design CRFs and EDM plans, and ensure data quality across projects.

Responsibilities include database setup, validation, SAE reconciliation, data entry oversight, and interaction with clients and vendors. English proficiency and CRO data management experience required.