Clinical Project Manager (m/f/i)
Job Description SummaryBD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. BD helps customers to enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Our location in Karlsruhe deals with the development and manufacture of minimally invasive products.
About the position
The Clinical Project Manager (m/f/i) is responsible for the execution of global clinical strategies generating clinical evidence for non-active and active medical devices (class II/III).
Management of overall study activities in accordance with the protocol, 21 CFR/ISO14155 and internal SOPs
Preparation of study documents, including, protocols, CRFs, Informed Consent Forms, budgets and project plans
Selection and management of external service providers
Effective communication with investigational sites and other internal/external stakeholders
Design and execute clinical trials and further types of data collection (pre-market, post-market clinical follow up)
Understand regulatory requirements for medical device studies in GER/AUT/SUI and larger EU countries
Prepare documents and obtain approvals from Ethics Committees and Competent Authorities
Manage clinical device supplies and logistics
Train site personnel (incl. Investigator Meetings), internal study team and vendor CRAs on device and study procedures
Ensure full compliance with safety reporting requirements according to applicable regulations
Participate in Site Initiation Visits and Monitoring Visits depending on project needs
Ensure timely enrollment and data collection in liaison with investigational sites and global Clinical Affairs
Assist in the preparation and review of study reports
Assist in regulatory submissions to Notified Bodies and international authorities
Collaborate with Clinical/Regulatory Affairs, Quality, R&D and Marketing departments
University degree (BSc, MSc, PhD) in Life Sciences, Medical Technology, Medicine, Pharmacy or related field.
Furthermore, you have:
5-year experience in clinical research in the medical device/pharmaceutical industry, CRO, or public research institution with relevant project experience
Proven Project Management experience in conducting multi-center clinical studies
Experience with study regulatory submissions
Ability to understand regulatory requirements and advanced device technology
Excellent communication skills in German and English (oral and written), a further EU language is a plus
Sound knowledge of MS office, open to take advantage of state of art technology
Good teamwork capabilities and effective reporting
Willingness to travel (20%)
Working in a global organization and with highly motivated teams
A familiar work climate in an innovative environment where your input counts
A safe workplace with long-term perspectives.
Flexible working from office or remote
We endeavor a long-term collaboration – hence corporate career planning throughout diverse phases of life conveys a high importance and value for us
BD office Karlsruhe
Primary Work LocationDEU Karlsruhe
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