Clinical Data Manager

Jefferson Wells; Monza; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading R&D company near Milan is seeking a Data Manager to oversee data management activities for clinical studies. The role involves ensuring data integrity and compliance with rigorous standards while developing necessary platforms and technologies to enhance data collection. This position presents an exciting opportunity for a skilled professional in a dynamic industry.

Competenze

• Experience in managing clinical data.
• Strong understanding of regulatory compliance (ICH/GCP).
• Ability to develop and integrate data platforms.

Mansioni

• Ensure data management activities are executed according to project timelines.
• Develop technologies for collecting clinical data.
• Perform database quality control and develop verification programs.

Conoscenze

Data management

Quality control

Compliance

Data integrity

Statistical analysis

Descrizione del lavoro

We are looking for a Data Manager on behalf of an R&D Company based near Milan.

The candidate will report to the Chief Scientific Officer and CEO of the Company.

Main responsibilities :

• Ensure data management activities of assigned studies are planned and executed according to project timelines, maintaining high standards of data integrity and quality, while adhering to budget constraints.
• Develop, test, and integrate technologies, systems, and data platforms needed for collecting and managing clinical data.
• Ensure compliance with ICH / GCP guidelines, applicable laws, and regulations for all clinical documentation.
• Perform or oversee outsourced interim and final database quality control, including developing computer programs to verify data consistency and plausibility.
• Review CRFs critically from a statistical and data management perspective, ensuring consistency with the clinical trial protocol and appropriateness of data collection.
• Produce or oversee the production of tables, figures, and listings for the Statistical Report and the statistical section of the Clinical Study Report.