Data Manager (M/F)

Gustave Roussy, the leading French and European cancer center, is recruiting a Data Manager within the Bureau de Biostatistique et d'Epidémiologie.

The Bureau de Biostatistique et d'Epidémiologie, attached to the Direction de la Recherche Clinique, designs and analyzes numerous French and international trials from phase I to phase III, observational studies, and meta-analyses.

As part of the management of phase I, II, III oncology therapeutic trials or clinical studies outside of trials, the Data Manager will perform the following tasks:

• Develop the case report form;
• Write data management documents (DMP, DVP, . . . );
• Ensure the creation of the database (TrialMaster software);
• Ensure the programming of consistency checks;
• Ensure the quality control of the database;
• Monitor patient inclusions;
• Ensure data review;
• Perform the generation of queries to be sent to clinical investigation centers;
• Validate data;
• Code adverse events (AEs) and reconcile serious AEs between the clinical database and the pharmacovigilance database;
• Write data-management reports;
• Participate in project steering meetings;
• Ensure the database lock;

Training:

Minimum BAC +3 Minimum 6 months of experience in data management

Skills:

Knowledge of regulatory requirements and Good Clinical Practices IT proficiency: knowledge of a database management system (DBMS). Programming skills (SQL, SAS, Java script) would be a plus, Good level of English allowing work in an international context. Beyond your data-management skills, you are recognized for your rigor, your autonomy, and your interpersonal skills (numerous exchanges with statisticians, project managers, ARC, investigators.)