Milvue, a pioneer in artificial intelligence for medical imaging, is seeking a Clinical Data Manager to join its clinical department under the leadership of the Medical Director.
This pivotal role is instrumental in the success of our innovative projects aimed at transforming diagnostics and treatment in the healthcare sector.
The position entails meticulous management of clinical data from collection through to submission, ensuring data quality and compliance with study protocols and planned statistical analyses.
Key Responsibilities :
Clinical Data Management : Oversee data management activities from clinical synopsis review to clinical data submission, including data collection and processing, ensuring adherence to timelines and budgets. Prepare regulatory documentation necessary for product certification. Actively participate in project follow-up meetings.
Supervision and Quality Assurance : Collaborate with the clinical department to supervise external providers, ensuring the quality and timeliness of deliverables, and guarantee clinical data compliance with study protocol requirements and planned statistical analyses.
Interdepartmental Collaboration : Coordinate and manage clinical data within Milvue’s BU. Facilitate communication and collaboration between various teams (clinical, product, support, QARA, and marketing) for internal research, product development, strategic decision-making, and regulatory compliance.
Contract start date : As soon as possible.
Education : Advanced degree (Master’s, PhD) in science, computer science, data management, biostatistics, or a related field.
Experience : Proven experience as a clinical data manager.
Technical Skills :
Advanced proficiency in Python and data science tools.
Knowledge of clinical research regulatory requirements, Good Clinical Practices (GCP), ICH guidelines, and best practices in Data Management.
Appreciated expertise in DICOM data standards.
Soft Skills :
Ability to work in a team and across departments, especially with technical and non-technical teams to translate needs into effective data solutions.
Excellent organizational, planning, and priority management skills.
Languages : Professional proficiency in English, both written and oral.
2 interviews minimum required with : Medical Director, Chief Scientific Officer (CSO)
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