For one of our clients, we are urgently looking for a Clinical project manager (CPM) medical devices.
Previous clinical project management experience is required, medical device experience is a plus.
Interested in a next step in your career? Don't hesitate, and apply as soon as you can!
You will be responsible for leading one or several clinical trials within the Clinical R&D Operations unit, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution.
• Serve as a Clinical Trials Leader within the Clinical R&D Operations group to execute company sponsored clinical trials for the Medical Device Franchises
• Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
• Serves as a member of the clinical trial/study/program core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility
• May serve as the primary contact for clinical trial sites
• Independently solves problems arising during clinical study execution, and will seek guidance for more complex problems, as needed
• Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
• Plan, track, and manage assigned clinical trials/programs budgets to ensure adherence to business plans
• Support the implementation of new clinical systems/processes, and provide support for publications, as needed
• Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities, contractors/vendors, and company personnel
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
• Requires knowledge of Good Clinical Practices
• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
• Previous experience in clinical trial management or equivalent is required
• Knowledge and understanding of application of regulations and standards applied in clinical areas/regions
• Effective leadership skills in a professional and ethical manner
• Strong written and oral communication skills in English, knowledge of Dutch and French is a plus
• Presentation skills and influencing of others
• Advanced technical writing skills
• Advanced project management skills with ability to handle multiple projects
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
• Medical device experience a plus.
015 21 11 04