The objectives of the European Medical and Clinical Division are to organize, manage and conduct clinical trials by respecting all regulatory requirements and Good Clinical practice, to communicate clinical data to wider audience, to manage all medical aspects of company products, and to contribute to the new products and new therapies development.
medical devices company, the clinical and medical department
Clinical data management
Performs ongoing data cleaning and reviews to assure quality of the data and compliance with SOPs, GCP and ICH Guidelines
Assist in eCRF development, Edit checks and UAT of clinical studies
Creates and delivers study-specific site training.
Partner with clinical operations personnel to manage the query lifecycle
Responsible for handling all pre and post production service requests
Assist PDM while developing and maintaining data management processes in compliance with Standard Operating Procedures (SOP)
Preparation and conduct of Clinical Trials
Ensure accuracy of clinical data through review of CRFs for completeness and consistency
Provide clinical data export or reports to clinical operations team
Partner with external service providers to support department goals
Closely follow the regulations related to conduct of clinical trials in different countries
Assist in updating DM processes to any change in regulation
Assist in SOP preparation and update
Act as representative of the company.
Assume all other responsibilities and authorities this function may require regarding new opportunities.
General monthly reporting to Program data manager and divisional manager
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