Job Description Summary
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Sr. Clinical Project Manager will:
Lead all aspects of the planning and execution of IVD clinical studies, including study timeline development, to ensure that results are completed on time and within budget.
Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents
Develop clinical study reports for submission to regulatory authorities
Develop and track the clinical study budget, including invoice review/approval and monthly accruals
Oversee and review deliverables produced by study team members to ensure quality and compliance
Manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
Ensure that studies comply with BD policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations
Recognizes potential problems, takes preventive steps, and recommends solutions.
Demonstrate understanding of BD’s general business functions, products, and procedures and serve on cross-functional project teams as a clinical study subject matter expert
Develop and implement standardized processes and operating procedures for conducting clinical research
Create and maintain clinical study documents as part of the trial master file (TMF)
Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants
Conduct on-site clinical monitoring activities as needed
Lead and actively participate in various cross functional team meetings
Ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded
Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States)
Preferred Qualifications:
Three (3) or more years of experience handling IVD clinical research studies from study planning to study closeout.
Previous experience leading or mentoring personnel.
Previous site monitoring and/or CRA experience.
Therapeutic knowledge and/or experience with infectious disease diagnostics including molecular or immunoassay platforms.
Education and/or Experience:
BA/BS (MA/MS preferred) in health science field or other relevant technical area or equivalent combination of training and experience in lieu of a bachelor's degree. Professional certification (clinical research, laboratory) is a plus.
Minimum 1 year of experience in clinical project management required
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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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.
PDN
Primary Work Location
USA MD - Sparks - 7 Loveton CircleAdditional Locations
Work Shift
79 jobs found