We are seeking a Clinical Data Manager to oversee all aspects of clinical and biosample data management for a large multicentre, prospective study. The role covers the design, implementation, and oversight of data management systems, compliance with regulatory standards, and coordination of data queries between clinical sites, vendors, and internal teams.
The ideal candidate will have strong experience in clinical data management, be meticulous in quality control, and possess the communication skills to ensure smooth collaboration with CROs, biobanks, laboratories, and internal stakeholders.
Main Missions:
· Data System Setup and Maintenance
o Design, implement, and validate the electronic Case Report Form in alignment with the study protocol.
o Oversee the setup and maintenance of the Laboratory Information Management System (LIMS) for biosample tracking.
o Ensure data systems are compliant with relevant regulatory requirements.
o Test systems and manage user access rights.
· Clinical Data Management
o Develop and maintain data management plans.
o Coordinate data collection, entry, and cleaning in eCRF.
o Implement and monitor data quality checks; generate and resolve queries with sites.
o Implement data interoperability via mapping with ontologies.
· Biosample Data and Metadata Management
o Oversee biosample metadata integration (collection date, type, storage location, processing status).
o Ensure proper linkage between clinical and omics datasets.
o Track biosample chain of custody from collection to vendor analysis.
o Generate and resolve queries with vendors
· Regulatory Compliance and Quality Assurance
o Act as point of contact for data protection compliance, working closely with the DPO.
o Maintain audit trails for all clinical and biosample data.
o Support preparation of regulatory submissions (e.g., CNIL, ethics committees) with data-related documentation.
· Cross-functional Coordination
o Liaise with CRO, clinical sites, vendors, and internal teams to ensure smooth data flow.
o Provide training to site staff on data entry and biosample tracking tools.
o Report progress and risks to the Clinical Operations Manager.
In addition, as we operate in a startup environment, we value adaptability. You may occasionally be asked to contribute to tasks outside of your core responsibilities. We estimate that up to 5% of your time may be dedicated to company-wide collaborative efforts.
Who we are looking for
· Master’s degree in life sciences, data management, bioinformatics, or related field.
· 3+ years of experience in clinical data management.
· Proficiency with EDC/eCRF systems and data queries resolution.
· Strong organisational skills and attention to detail.
· Full proficiency in English
How to stand out
- You have high agency, look for solutions rather than problems and you are a team-player willing to go beyond your job description
- You are familiar with a start-up environment
· You have previously worked in the immuno-inflammation space
· You are familiar with precision medicine and artificial intelligence
Type d'emploi : Temps plein, CDI
Statut : Cadre
Rémunération : 40 733,82€ à 85 237,82€ par an
Avantages :
- Prise en charge du transport quotidien
- RTT
- Travail à domicile occasionnel
Lieu du poste : En présentiel
Date limite de candidature : 01/10/2025