Job Description Summary

As Senior Clinical Project Manager, you will be responsible for the implementation, execution, and oversight of assigned clinical studies. You will independently build efficient and engaged project teams and address 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. Assigned clinical studies are typically large and complex and data will be used to support regulatory filings.

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. 

Key responsibilities will include:

• Direct 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) necessary 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 milestones 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 necessary)

• Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants

• Oversees device shipments and inventory (including inventory forecasting)

• Forecast, manage, and track 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

• Ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded

About you: To be successful in this role, you will possess:

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

• 25% travel is required.

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

• Minimum of two (2) years clinical project management experience, ideally in the medical device industry

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

• Ability to work independently, and manage multiple projects in a fast-paced environment, and effectively navigate obstacles

• Demonstrated 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

• Strong communication, presentation and cross-collaboration skills

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.  

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