Clinical Project Manager - Medical Device
An opportunity has opened for an experienced Clinical Project Management professional to join a young & growing Medical Devices company based in Berlin. This is a newly created role within the company and you'll be the first person in the Clinical team, so you'll need to be a well experienced and capable individual to succeed in this position.
You'll be taking the lead in developing, conducting, evaluating/ documenting clinical investigations for their devices and you'll be the driving force behind their clinical affairs/ operations activities and as integral part of the team responsible for our success.
- Develop clinical evaluation strategies and elaborate investigations including authorisation for their devices to monitor their safety and efficacy and to meet regulatory requirements
- Perform literature searches/ reviews as necessary to obtain and maintain up to date knowledge for effective clinical evaluations and investigations
- Take the lead in conducting and evaluating clinical investigations
- Document clinical investigations including study reports, summaries of safety and clinical performance. Develop and update clinical evaluation reports
- Manage the quality, accuracy, and timely production of clinical study plans and reports
- Support risk management activities like product risk analyses and benefit-risk assessments
- Support vigilance case (complaints, incidents) evaluations
- Close cooperation with R&D, regulatory affairs, quality management and sales & marketing and with external clinical sites, CRAs, medical advisor, regulatory authorities and notified bodies
- University degree in science
- At least 3 years of professional experience in leadership / project management of clinical investigations of medical devices
- 5 years' experience as Clinical Research Associate (CRA) with the ambition to take the next step and become a clinical study manager, or currently employed as a clinical study manager or clinical project manager with previous site monitoring experience
- Experience in performing systematic literature searches and in scientific / medical writing
- Excellent presentation and moderation skills, including technical editing and QC skills
- Good understanding of statistics, together with the ability to interpret complex clinical data
- Team oriented, accurate and self-dependent personality with an analytical working style and strong communication skills toward authorities, clinical staff and internal stakeholders
- Knowledge of MEDDEV 2.7/1,MEDDEV 2.7/2, MEDDEV 2.12/2, ISO 14155 and MDR requirements to clinical evaluations / clinical investigations
- Experience with Risk Management, ISO 14971 and FMEAs is a plus
- Excellent command of spoken and written English
This is an office-based position in Berlin. Relocation for the right candidate from across Europe is also an option but you'll need to be based in Berlin for a minimum of 3 or 4 days per week post Covid 19.