Clinical and Human Factors Specialist
il y a 1 jour
**Job Description Summary**: The Clinical & Human Factor Specialist (CHFS) is an integral position within the BDM-PS Clinical & Human Factor Development group within the Medical and Scientific Affairs Department of BD Pharmaceutical Systems. The CHFS has responsibility for generation of evidence supporting claims of BDM-PS products.
He/she is responsible for developing, supervising, executing, and reporting of studies (clinical trials and Human factors studies in compliance with BD policies and procedures, to contribute to Medical Devices development.
He/she participate in core teams to represent Medical and Scientific Affairs in development phases when a study is in preparation.
The CHFS responsibilities for managing studies for the allocated products under development includes the following:
- Writing and updating the Clinical Development Plan (CDP)
- Contributing to task analysis, use FMEA, IFU building and validation
- Contributing to developing evaluation of BD products (methods and capabilities) to assess end-users acceptance, preference and willingness to adopt the medical device
- Building study design based on validated CDP
- Establishing an appropriate budget and timeline for the study with input from the corresponding project core team
- Working with his/her line manager to ensure support from C&HF expert team members to get support for various element of the study, and with other piers e.g. Statistician to design the study
- Ensuring appropriate selection, tender management, evaluation of proposals, and once the supplier chosen, training of study supplier; acquire signed supplier documents (contract) within study timelines, up to the approval of final payments
- Establishing investigational products specifications for HF studies in collaboration with R&D and the Laboratory (externally or internally) and supervising the preparation of the corresponding products on time and in compliance with defined budget
- Writing/reviewing study documents, as needed such as protocol, CRF, consent form, session guide, database, clinical study report
- Assure IRB approval if needed and applicable
- Maintaining study documentation into the central study file
- Supervising the interface with data management and statistics in developing case report forms, managing data cleanup, and analyzing study data
- Completing final study report and closing of study file, contributing to publication writing
**Primary Work Location**: FRA Le Pont-de-Claix Cedex
**Additional Locations**:
**Work Shift**:
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