Data Manager CMC

Excelya; Saclay; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

A mid-size CRO in healthcare seeks a Data Manager – CMC to oversee data integrity for high-quality products. This role requires a minimum of 3 years of experience in data management within chemistry, manufacturing, or regulatory contexts. Key skills include proficiency in data management software and strong communication abilities. The company promotes a culture of excellence and teamwork in enhancing the patient journey.

Qualifications

• Minimum 3 years in data management within chemistry, manufacturing, or regulatory environments.
• Strong understanding of CMC data requirements and quality control.
• Fluency in English required; additional languages are a plus.

Responsabilités

• Organize and improve data quality per rules set by Data Owner.
• Implement data integrity rules and monitor reporting.
• Handle data access, migration, and archiving.

Connaissances

Data management

Quality control

Regulatory compliance

Communication

Organizational abilities

Attention to detail

Formation

Degree in Life Sciences, Data Management, or related field

Outils

SQL

Power BI

Description du poste

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).

Requirements

About You

• Experience: Minimum 3 years in data management within chemistry, manufacturing, or regulatory environments.
• Skills: Strong understanding of CMC data requirements, quality control, and regulatory compliance.
• Tools: Proficient in data management software, databases, and data visualization tools (e.g., SQL, Power BI, or similar).
• Education: Degree in Life Sciences, Data Management, or related field.
• Languages: Fluency in English is required; additional languages are a plus.
• Soft Skills: Excellent communication, organizational abilities, and attention to detail.

Benefits

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid‑size CRO with the best employee experience. Our one‑stop provider service model – offering full‑service, functional service provider, and consulting – enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.