Job Information
BD (Becton, Dickinson and Company) Clinical Project Manager (m/f/d) in Karlsruhe, Germany
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, NLD Drachten - Marconilaan
Work Shift
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.