Senior Data Manager

Osivax is a growing biotechnology company focused on innovative vaccine development . They have offices in Lyon, France and Liège, Belgium. They are looking for a Senior Data Manager . You will be reporting to the Chief Medical Officer.

This role may evolve into a Head of Data Management position as the scope grows, provided the candidate demonstrates strong leadership capabilities and alignment with the company’s strategic development.

Responsabilities

As Senior Data Manager , your role combines senior operational execution and strategic ownership of data management activities, with the scope to grow into a formal leadership position as the organization scales.

Your main responsibilities are :

• Own and operate data management processes end to end, manage and supervise clinical study data from collection through database lock.
• Ensure data quality, integrity with regulatory compliance according to ICH-GCP, using CDISC standards (SDTM/ADaM).
• Review, develop and maintain data management plans and reports, CRFs, data validation specifications, and documentation.
• Perform statistical analyses in collaboration with senior biostatistician using SAS or other statistical software (e.g., IBM SPSS, R, STATA, etc.).
• Review, program and validate statistical outputs including tables, listings, and figures (TLFs).
• Support publications and develop appropriate figures (using GraphPrism), tables and supplementary materials.
• Collaborate with cross-functional teams including clinical development and clinical operations, quality, medical writing, and regulatory affairs.
• Manage external vendors (CROs), contractors and sub-contractors.
• Support data review meetings, audits, and inspections as needed.
• Drive process improvement initiatives of internal QA procedures, develop related SOPs and promote best practices for data integrity and statistical rigor.

Profile

• Master’s or PhD’s degree in Data Management and Biostatistics .
• 8-10 years of Data Management experience as an individual contributor in a CRO, biotech or pharmaceutical company.
• Programming experience in SAS or other data management and statistical software.
• Professional working proficiency in English (spoken and written), good knowledge of French would be a plus.
• Solid understanding of clinical research processes, ICH-GCP, and regulatory requirements.
• Experience working with CDISC standards (SDTM and ADaM).
• Excellent analytical, problem-solving, and documentation skills.
• Ability to work collaboratively in a fast-paced, multidisciplinary environment.
• Experience in vaccine clinical trials or infectious disease studies is an asset.
• Familiarity with data visualization tools (e.g., GraphPrism) is an asset.
• Experience interacting with external partners or global project teams is an asset.

Offer

• A dynamic and collaborative work environment.
• Opportunities for professional development and advancement.
• The chance to contribute to meaningful clinical research with global impact in the vaccine area.
• Competitive compensation and benefits package.