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.
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