Freelance/ Contract Italian Speaking Clinical Data Manager
AL Solutions, Italy

I am seeking an experienced Clinical Data Manager to join my clients team. The ideal candidate will be responsible for ensuring the integrity, accuracy, and completeness of clinical trial data collected throughout the clinical trial process. This role involves managing all aspects of clinical data management, including data collection, cleaning, validation, and reporting.

Responsibilities:

• Develop and implement data management plans (DMPs) in accordance with regulatory requirements and industry standards.
• Oversee the design and implementation of electronic data capture (EDC) systems and other data collection tools.
• Collaborate with cross-functional teams to ensure data quality and integrity throughout the clinical trial lifecycle.
• Develop and maintain standard operating procedures (SOPs) for data management processes.
• Conduct database lock activities, including final data review and reconciliation.
• Generate and distribute clinical trial reports, including interim and final study reports.
• Ensure compliance with relevant regulatory guidelines, including Good Clinical Data Management Practices (GCDMP) and Good Clinical Practice (GCP).

Requirements

• Minimum of 5 years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
• Proficiency with electronic data capture (EDC) systems and data management software (e.g., Medidata Rave, Oracle Clinical).
• Strong understanding of clinical trial processes and regulatory requirements (e.g., FDA, EMA, ICH guidelines).
• Ability to manage multiple tasks and priorities in a fast-paced environment.
• Experience with data analysis and reporting tools (e.g., SAS, R) preferred.

Benefits

12 months contract - 5 days per week - asap start date - outside IR35

Job Rewards and Benefits