Clinical Data Manager

The Clinical Data Manager aims to provide the development team with curated, high-quality data.

 

Responsibilities:

• Acquisition of data (samples, images, clinical and diagnostic annotation) from existing and new clinical partners.

• Quality assurance and curation (incl. data cleaning) of acquired data (clinical, diagnostics, imaging)

• Development, implementation, and validation of plausibility checks.

• Preparation and maintenance of study-specific data management plans.

• Ensure compliance with regulatory requirements (e.g., local data protection regulations) and industry standards.

• Prepare and maintain data management documents, including. SOPs.

• Coordinate the annotation of image-based datasets by medical experts, ensuring accuracy and consistency

• Collaborate with computer vision and clinical experts to understand data requirements and adjust annotation processes accordingly

 

Background and skills:

• Master’s degree (or higher) in life sciences, bioinformatics, data science, or medicine with work or research experience in a clinical or diagnostic setting.

• 3-5 years of experience in clinical data management, preferably in the diagnostics, pharmaceutical industry, or CRO.

• Strong proficiency in python, and familiarity with packages such as Biopython, OpenCV, and OpenSlide.

• Work with clinical laboratory systems to transfer data across heterogeneous storage environments and protocols (NAS, cloud, SFTP, APIs, HL7) 

• Knowledge of regulatory requirements (FDA, IVDR, ICH GCP, etc) is a plus.

• Strong quality awareness, independence, and clear, audience-appropriate communication. 

• Effective communication and interpersonal skills. Business proficiency in French and English. Additional languages are a plus.

• Ability to work independently and in remote teams.

• Availability to travel regularly.