Job Description Summary

The BD Interventional Surgery Business Unit develops innovative, life-enhancing devices in the fields of surgical interventions that not only meet clinical needs but also deliver value to health systems and improve the lives of patients. Clinical Affairs/Clinical Operations is part of the Medical Affairs organization. The role of Clinical Affairs/Clinical Operations is to design and execute clinical research in order to ensure that high quality data are collected in compliance with applicable standards, guidelines, and regulations.

The Senior Clinical Project Manager is responsible for the implementation, execution, and oversight of their assigned clinical studies. The Senior Clinical Project Manager (Sr CPM) builds efficient and engaged project teams and addresses the day-to-day, complex issues affecting all facets of clinical study development and execution. Ongoing planning, risk assessment, analysis and problem solving are critical to the success of this position. The Sr. CPM is expected to require limited oversight for the day-to-day functions/responsibilities of managing clinical studies.

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 creativity 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 ground-breaking 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.

Job Summary:

The BD Interventional Surgery Business Unit develops innovative, life-enhancing devices in the fields of surgical interventions that not only meet clinical needs but also deliver value to health systems and improve the lives of patients. Clinical Affairs/Clinical Operations is part of the Medical Affairs organization. The role of Clinical Affairs/Clinical Operations is to design and implement clinical research in order to ensure that high quality data are collected in compliance with applicable standards, guidelines, and regulations.

The Senior Clinical Project Manager is responsible for the implementation, execution, and oversight of their assigned clinical studies. The Senior Clinical Project Manager (Sr CPM) builds efficient and engaged project teams and addresses the day-to-day, sophisticated issues affecting all facets of clinical study development and execution. Ongoing planning, risk assessment, analysis and problem solving are critical to the success of this position. The Sr. CPM is expected to require limited oversight for the day-to-day functions/responsibilities of managing clinical studies.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Advise the planning and execution of assigned clinical studies

• Ensure compliance with company standards, policies and procedures, Good Clinical Practice (GCP), and other applicable regulations

• Develop study materials (i.e., protocols, case report forms, monitoring plans, interim and final reports) vital for the conduct of quality clinical studies

• Creatively apply experience and know-how to maintain timelines, quality, and budgets (e.g., developing subject retention strategies or inspection readiness plans)

• Lead project team meetings and facilitate information exchange among team members to keep study achievements on-track and to overcome obstacles

• Interacts with team members to ensure all study operational documents, CTMS, Trial Master Files and clinicaltrials.gov content for assigned studies are maintained and documentation is audit ready at all times

• Lead site identification and selection activities and ongoing site management (including site visits, as vital)

• Supervises device shipments and inventory (including inventory forecasting)

• Forecast, manage, and supervise overall clinical study budgets (headcount and internal/external costs) to maintain or accelerate timelines and ensure fiscal responsibility

• Manages vendor relationships through effective communication and efficient interactions to optimize clinical study performance and adherence to scope of work

Education and Experience:

• Bachelor’s degree, or equivalent, in medical, health, or life sciences field; Master’s degree in a related field preferred

• Minimum of five (5) years clinical research experience, ideally in the medical device industry

• Experience in/exposure to hospital operating rooms is a plus

Knowledge and Skills:

• Proficient knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, MDR/IVDR and current industry practices related to the conduct of clinical studies

• Proven project management skills including developing study protocols, participating in database development, managing study budgets, and supporting monitoring activities.

• Development and use of clinical information technology (e.g., CTMS).

• Ability to understand and interpret technical, scientific, and clinical information as it applies to product approval activities.

• Proficiency with Microsoft Office Suite applications.

• Excellent interpersonal communication and organizational skills.

• Ability to travel up to 20%

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 creativity and aim 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

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Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift

NA (United States of America)