Data Manager Cmc H/F - 78

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work : our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to BE part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to BE Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking a Data Manager - CMC (Chemistry, Manufacturing, and Controls) to support our commitment to high-quality products. In this vital role, you will oversee and ensure the integrity of data generated. You will work closely with research and project teams to deliver actionable insights through rigorous data management practices.

Main Activities :

Organize and improve data quality per rules set by Data Owner.
- Document data, metadata, lifecycle (catalog, contracts, process map)
- Apply data quality rules, automate, monitor flows/reporting
- Implement data integrity rules
- Ingest data to cloud platform (GCP), communicate with stakeholders
- Integrate new assets, Write data transfer specs; Perform quality controls
- Handle data access/migration/archiving
- Apply licensing terms for external data; Main contact for external data providers
- Harmonize/standardize/prepare data for analysis
- Share best practices with the DM community

Deliverables :
- Datasets prepared in the desired formats.
- Data sources ingested into GCP - Google Cloud Platform.
- Automated solutions for data quality control and monitoring.
- Data archived in EVA (Group tool for archiving), according to global rules.
- Regular reporting to the Data Management R&D coordinator.

CMC :

Knowledge of chemistry, pharmaceutical development (galenic, biology), and industrial development; functional understanding of applications managing data and the links between applications (eLN, LIMS, MES).