BD (Becton, Dickinson and Company) Clinical & Human Factors Study Specialist in Le Pont, France
Job Description Summary
The Clinical & Human Factors Study Specialist (CHF-SSp) is an integral position within the BDM-PS Clin & HF team of Medical Affairs department. The CHF-SSp has the responsibility to provide guidance and support to Clinical & HF Program Leader (CHF-PL) for the HF studies.
It is expected that the CHF-SSp acts as a leader in the Medical Affairs department, and mentors other individuals formally or informally. The CHF-SSp is expected to set an example with respect to work ethic, maturity, and adherence to ISO standards, Industry best practices, and BD guiding principles. The CHF-SSp is expected to contribute as required to cross department and corporate initiatives, and to share its expertise.
CHF-SSp will ensure that methods applied by BDM PS for the study conduct are effective and meet regulatory and customer expectations.
In particular, he/she will be responsible to define which elements are required for an effective HF study conduct and will develop and update corresponding templates adapted to the HF study type when necessary
He/she will support CHF-PL to ensure that department practices are applied. For studies conducted by R&D, CHF-SSp will liaise with R&D associates to ensure that documentation is sufficient and appropriately reviewed to ensure relevance of conclusions.
Protocol preparation, study planning, and instructions to suppliers: He/she will participate to constructive challenges / study deliverables review committees e.g protocol CRF, instruction to suppliers, review of supplier documents to ensure that best practices in study conduct are applied consistently with study objectives and types
Tested products : He/she may support CHF-PL regarding study product specification and management in collaboration with the Laboratory (externally or internally), in respect to study timeline and budget
Study session conduct: CHF-SSp will review material generated by HF supplier (session guide, …). When relevant, he/she will develop BDM PS guidelines to increase consistency and efficiency of study conduct. He/she will liaise with HF suppliers for implementation. He/she may support CHF-PL regarding on site supervision or conduct of session if necessary.
Post study session activities: maintain report consistency according to session content and report preparation will be conducted under CHF-PL responsibility.
HF supplier selection and audit: In collaboration with Clin&HF Sernior Manager, auditors, will play a key role in HF supplier qualification. CHF-SSp is supposed to have an auditor qualification
Provides expertise to CHF-PL in management of supplier selection : he/she provides guidance in establishing the list of consulted suppliers, analysis of the quotations received, and helps CHF-PL to take final decision
Supplier Pre-study meetings: He/she will participate to pre-study meetings and will act as expert. In case of misalignment between project team and the supplier, he/she will provide recommendation to Clin&HF Sr Manager to facilitate arbitration.
The CHF-SSp is expected to attend and complete assigned training courses concerning medical devices, human factors, and to share any new relevant information & benchmark element with the Clin & HF team members.
Participates in establishment and updating of the SOP’s related to the HF study set up activities.
The CHF-SSp is expected to attend HFE congresses and to give feedback on competition practice and benchmark and to share any new relevant information with the Clinical & HF team members
For conduct of early studies potentially leaded by R&D, CHF-SSp is supposed to set up networks enabling quick access to relevant experts and/or Health Care Professionals (HCP) this enabling agility in response to ad hoc problems and/or conduct of basic user studies
Primary Work Location
FRA Le Pont-de-Claix Cedex
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.