Senior Clinical Data Manager

The Senior Data Manager reports to the Data Manager Project Coordinator, ensuring clinical data is managed in compliance with applicable standards, regulatory guidelines, and OPIS SOPs.

Requirements

• Bachelor’s degree
• At least 4 years of experience in CRO, biotech, pharma, research institutes or 3 years in similar role
• Solid knowledge of ICH-GCP/ISO14155, clinical data management, and HA requirements pertaining to pharmaceutical research and specifically to Data Management
• Digital skills and good knowledge of FDA 21 CFR Part 11 and system validation
• Solid knowledge on relational databases and programming languages
• Knowledge of CDISC standard specifications
• Knowledge of SAS system is a plus
• Excellent knowledge about Microsoft package
• Strong commitment to quality
• Flexibility and propensity for innovation
• English language (fluent reading, writing, and verbal skills)
• Planning and organizational skills
• Communication skills
• Result-oriented
• Team-working oriented

Benefits

• Competitive salary
• Other benefits/bonuses