Clinical Data Management Lead — CDISC & QA

Opis; Lazio; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A full-service biotech-focused company in Italy is seeking a Senior Data Manager to oversee clinical data management, ensuring compliance with regulatory standards. The ideal candidate will have over 4 years of experience in the field, strong digital skills, and a commitment to quality in clinical trial management. Opportunities for professional growth are provided within a dynamic and expanding environment.

Servizi

Competitive salary

Career development opportunities

Other benefits and bonuses

Competenze

• At least 4 years of experience in CRO, biotech, pharma, or similar role.
• Solid knowledge of FDA 21 CFR Part 11 and system validation.
• Knowledge of CDISC standard specifications.

Mansioni

• Ensure data is managed in compliance with CDISC and regulatory guidelines.
• Prepare and validate Data Management documents.
• Manage database lock and ensure quality controls according to Data Management Plan.

Conoscenze

Clinical data management

Knowledge of ICH-GCP / ISO14155

Digital skills

Strong communication skills

Team-working oriented

Fluent English

Formazione

Bachelor’s degree

Strumenti

SAS system

Microsoft Office

Descrizione del lavoro

A full-service biotech-focused company in Italy is seeking a Senior Data Manager to oversee clinical data management, ensuring compliance with regulatory standards. The ideal candidate will have over 4 years of experience in the field, strong digital skills, and a commitment to quality in clinical trial management. Opportunities for professional growth are provided within a dynamic and expanding environment.