Clinical Project Manager, International Full time/Part time
Job Description Summary
We are the makers of possibleBD 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.
Job Description
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!
We are offering more flexibility! This position can be either full time or part time based on need and individual agreement.
The Associate Clinical Project Manager, International is responsible for the compliance with regulatory requirements (EU MDR) related to clinical evidence and clinical documentation of the BDPI portfolio.
This position is embedded in a cross-functional team of Clinical Project Managers, CRAs, Medical Writers and stakeholders of other departments.
Your responsibilities will include:
- Support the development and maintenance of Clinical Evaluation Plans/Reports, Post-market Clinical Follow-up Plans/Reports in compliance with applicable regulatory requirements (e.g. EU MDR, MDCG)
- Represent Clinical Affairs in cross-functional teams to support international product registrations and audits from EU Notified Bodies and Proficient Authorities
- Assist in planning and execution of pre- and post-market clinical strategies
- Develop Clinical Investigation Plans, Informed Consent Forms and other study-related documents
- Prepare study submission files and interact with Ethics Committees and Proficient Authorities
- Collaborate with various functions in the BD Clinical Affairs Team and external service providers (CROs, consultants)
- Site Management and regular interaction with clinical investigators and other site staff
- Assist with electronic Trial Master File (TMF) maintenance and the conduct of TMF audits
- Plan and implement efficient processes for device management and other study supplies
- Support the Post-Market-Surveillance process and related documentation
Your Profile:
- Bachelors Degree or equivalent
- Background in Project Management
- Experience in clinical trails
- International mentality
- Willingness to travel within GSA & CEE region - 10%
- Proficiency in English
- Conversational level of German
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
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Primary Work Location
DEU KarlsruheAdditional Locations
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