Job Description Summary

The successful Clinical Project Manager (CPM) will participate in cross-functional project teams to plan and execute successful clinical studies, from concept through study completion, in support of corporate objectives. Additionally, the PM ensures that projects are completed on time, within budget, and in compliance with all regulatory requirements, Good Clinical Practice, & industry standards. The PM also provides oversight of the day-to-day activities of study team members and conducts personnel development and line management as needed.

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.

Why join us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

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.

Become a maker of possible with us!

Key responsibilities:

Under the direct supervision of the Director, Clinical Program Manager and/or Sr. Clinical Project Manager, the CPM will:

• Oversee the planning and execution of clinical studies, including clinical study timeline development, to ensure that deliverables 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
• Demonstrate understanding of BD’s general business functions, products, and procedures and serve on cross-functional project teams as a clinical subject matter expert
• Develop and implement standardized processes and operating procedures for conducting clinical research
• Supervise department personnel as needed
• 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
• Responsible for timely creation and maintenance of clinical study registration and updates

Required Qualifications:

• BSc/MSc/PhD in LifeSciences, Biomedical Engineering, Medicine or similar background
• Five (5) or more years of experience in Clinical Research
• Three (3) or more years of experience managing clinical research studies
• Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studies
• Experience submitting and managing studies in the EU under the MDR.
• Ability to work independently, manage multiple projects and personnel in a fast-paced environment, and effectively navigate obstacles
• Excellent English communication skills (oral and written)
• Strong computer skills, Proficiency with Microsoft Office Suite applications, experience working with eTMF, CTMS and EDC systems.
• Ability to travel up to 20%

Preferred Qualifications:

• Three (3) or more years of experience managing medical device studies
• Previous experience managing or mentoring personnel
• Previous site monitoring and/or CRA experience
• Therapeutic knowledge and/or experience with vascular disease
• Experience with study design and development
• Ability to communicate in German, French, and / or Dutch

Click on apply if this sounds like you!

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.

To learn more about BD visit: https://bd.com/careers

Primary Work Location

DEU Karlsruhe

Additional Locations

BEL Olen, IRL Wexford - Enniscorthy

Work Shift