Clinical Human Factors Manager (HYBRID)
Job Description Summary
HYBRID (2-3 days onsite)
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Clinical & Human Factor Specialist (CHFS) is an integral position within the BDM-PS Clinical & Human Factor Development group within the Medical 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 Affairs in development phases when a study is in
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, 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
Maintaining study documentation
Completing final study report and closing of study file, contributing to publication writing Clinical studies may range from simulated use studies (employing a patient or health care worker to use the device in a simulated environment; e.g. Human Factor studies) to complex studies in human subjects that may include drug/device combinations.
The CHFS interacts with product core teams and members:
Represents Medical Affairs in several core team and cluster handling new product development
Is accountable to the core team leader for deliverables of the Medical Affairs function
Leads the overall planning, leadership and execution of all activities related to Medical Affairs function
Provides work direction to the product safety and clinical development extended team members with direction in regards to the project
Estimates resources requirement and identifies resources in conjunction with functional managers
Ensures deliverables produced by Medical Affairs function meet the appropriate quality standards
Communicates progress and facilitates decision making with the core team and Medical Affairs function
Prepares and delivers presentations covering relevant Medical Affairs information (functional capabilities and clinical and HF study data) to customers during TC and face to face customer meetings
The CHFS is responsible for assuring that study is conducted with HF guidelines (HF studies) and all National and Local Regulations.
The CHFS participates in establishment and updating of the SOPs related to the C&HF development activities.
The CHFS is also expected to attend and complete assigned training courses concerning medical devices and human factors.
It is expected that the CHFS acts as a leader of the Medical Affairs department, and mentors other individuals formally or informally.
The CHFS is expected to set an example with respect to work ethic, maturity, and adherence to Regulations and Guidelines, industry best practices, and BD guiding principles.
The CHFS is expected to contribute as required to cross department and corporate initiatives, and to share their expertise.
The CHFS may be expected to travel intermittently as required to achieve his/her routine responsibilities.
He/she must be available for limited domestic or international travel as-needed basis within any C&HF study (mainly for study conduction in Europe, in USA, and potentially in Asia). Travel should not exceed 25 percent of his/her time.
Education Scientific background, (Biomedical Engineering, Masters or PhD in Biological Sciences, or PharmD preferred)
Experience 3 years of preferably simulated studies experience, within the Pharmaceutical or the Medical device industry, with good understanding and knowledge of Medical device environment (including design control); regarding applicable Quality / Regulation, a good understanding and operational knowledge of national regulations and a good understanding of international regulations.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA NJ - Franklin Lakes
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ