Data Manager – Clinical Studies, Pharmaceutical & Cosmetic

Job not on LinkedIn

October 30

🗣️🇫🇷 French Required

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Logo of ALTEN

ALTEN

Engineering • IT Services • Aerospace

ALTEN is a leader in outsourced Engineering and R&D and IT Services, catering to various industries such as aeronautics, automotive, banking, and life sciences. With a workforce of over 57,400 employees across nearly 30 countries, ALTEN specializes in executing complex and technical projects, supporting innovation and technology advancements in multiple sectors. The company focuses on providing engineering services, project management, and IT solutions to enhance client operations and foster sustainable innovation.

10,000+ employees

🚀 Aerospace

📋 Description

• Manage, structure, and perform quality control on data from clinical studies (pharmaceuticals, medical devices, cosmetic products) • Ensure regulatory compliance of data according to international standards (ICH-GCP, FDA, EMA, etc.) • Collaborate with R&D, pharmacovigilance, and biostatistics teams • Implement data management strategies: data collection, cleaning, validation, and integration of clinical data • Define and maintain clinical databases (eCRF, CDISC, SDTM, ADaM) • Contribute to statistical analysis and preparation of regulatory submission dossiers • Write technical data reports, listings, clinical tables, and traceability documentation • Support automation of data processes and continuous process improvement

🎯 Requirements

• Master's degree / Engineering degree (Bac+5) in Data Science, Bioinformatics, Biostatistics, or Digital Pharmacology with 3 years of experience • In-depth knowledge of clinical data management • Experience with pharmaceutical or cosmetic trial data • Proficiency in SAS / SQL / R / Python for clinical data analysis • Knowledge of CDISC standards, SDTM, ADaM • Understanding of GCP, FDA, EMA regulations • Experience with eClinical tools (Medidata, Oracle Clinical, Veeva Vault) • Knowledge of pharmacovigilance best practices • Analytical mindset and scientific rigor • Ability to work in a regulated environment • Communication skills with medical and scientific teams • English: required (documentation and international communication) • French: highly appreciated depending on the client.

🏖️ Benefits

• Diverse career paths with opportunities for advancement, internal, sectoral and geographic mobility, and role mobility. • Certified and degree-granting training programs. • Regular company events that combine well-being and performance.

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