Data Manager Project Lead - International Laboratory

We are looking for an ambitious professional to join the dynamic team of this leading pharmaceutical laboratory, ranked among the top three in France and led by a family structure. This company stands out for its national production of 95% of active ingredients and its established presence in over 20 countries.

Strongly committed to innovation, particularly in the fields of cardiology and oncology, it aims to maintain its leadership position. As a family-owned enterprise, it provides stability and commitment to the well-being of its employees, thus fostering a stimulating and rewarding work environment

Main Responsibilities

Drives data management activities for clinical studies in accordance with internal procedures, Good Clinical Practices, and CDISC requirements. Defines data management strategy for studies and adjusts it as needed (study build, data collection, cleaning, risk management, data review...). Coordinates DM activities handled by CROs to ensure studies are conducted within defined timelines, quality standards, and budgets. Provides oversight of CROs and ensures quality control of deliverables. Ensures consistency and homogeneity of collected data across all clinical studies.

Required Profile

6 to 10 years of experience in Clinical Data Management Knowledge of applicable regulatory requirements in clinical research, Good Clinical Practices (GCP), ICH guidelines, Good Data Management Practices, and CDISC requirements. Mandatory experience in Oncology. Experience in dossier preparation for registration and inspections, with at least 4 months of support preparation. Good understanding of information systems and database structures. Proficient level of English is essential.

If you have solid experience in clinical data management, a passion for innovation, and a desire to contribute to the success of a dynamic company, don't miss this opportunity!