Description de l'emploi
工作描述Purpose of the function:
The Clinical Research Project Manager will be the key contact point for the whole organization regarding the preparation, set-up and follow-up of clinical investigations. He/she will manage internal representatives (Project managers, R&D directors, ..) as well as suppliers (CRO’s, clinical partners). He/she will act as a subject matter expert for clinical investigations, to ensure clinical investigations are carried out according to regulatory requirements, ISO 14155 and IBA QMS.
- Review current QMS, identify gaps and amend/implement necessary QMS processes to allow for clinical investigations.
- Align and inform IBA relevant departments on potential clinical investigations
- Select CRO appropriate for the clinical investigation following supplier approval process.
- Review and approve clinical investigation documents such as, but not limited to, protocol, statistical analysis, study reports
- Submit necessary documentation to competent authorities and ethic committees for approval of clinical investigations.
- Report adverse events to appropriate competent authorities when necessary.
- Follow-clinical investigations with the help of a CRO.
- Support external audits from regulatory bodies regarding clinical investigation aspects.
- Ensure clinical investigations are properly monitored (site visits or CRO audit)
- Provide clinical investigation input for the Clinical Evaluation report
- University Degree.
- A minimum of 3 years of experience in Medical device environment and clinical investigations.
- ISO 14155 experience.
- Good knowledge of MS Office, SharePoint, Flowcharting software, Acrobat, etc.
- Good oral & written communications skills and ability to act as a facilitator and / or educator with strong leadership skills.
- Adaptable and willing to take on multiple new tasks and responsibilities.
- Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time.
- Process oriented, logical, analytical, meticulous, highly organized and able to analyze data & implement solutions.
- Willingness to travel.
- Fluent in English
公司Who are we?
IBA is a listed company, headquartered in Belgium, and employs 1500 people across the globe mobilizing their skills and passion to Protect, Enhance and Save lives
We develop, manufacture and support innovative equipment and software solutions for diagnostic, cancer treatment, and industrial applications.
Innovating for life since more than 30 years, IBA has opened new ways to diagnose and fight cancer and become the worldwide technology leader in the field of Proton Therapy, which is today the most advanced technologies treatment against cancer. Our core particle accelerators knowledge is unparalleled, with 100,000 patients treated on our proton therapy solutions and over 550 accelerators in operation globally.
One Mission, 4 business lines
IBA ‘s world class expertise lies in the development of:
next generation Proton Therapy technologies
Radiopharmaceuticals providing oncology care providers with premium quality services and equipment
Dosimetry advanced solutions for Quality Assurance of medical equipment and increased patient safety
particle accelerators for the Industrial and medical world.
Our 4 business lines are employing more than 1,500 passionate professionals worldwide dedicated to our Mission: Protect, Enhance and Save lives.
At IBA we dare to develop innovative solutions pushing back the limits of technology. We achieved worldwide recognition in our field by supplying the world's top oncologists with the most precise, cancer-defeating, technologies.
If you are passionate, cause-driven, you can make this quest yours by joining our dedicated colleagues and give your career a new meaning.
聘用意向书The identity of IBA is characterized by a group of colleagues driven by motivation, curiosity, creativity, the desire to learn on a daily basis, by technical challenges and above all by a highly developed team and family spirit that makes the daily life smoother and more enjoyable!
By joining a team of about 40 nationalities and working on more than 45 different sites on 3 continents, IBA offers you the opportunity of a meaningful career with a direct impact in the fight against cancer.
We are driven by:
- Innovating in a cutting-edge technology environment
- Developing professional and personal skills by learning on the Job; by participating in challenging projects; top class courses
- Evolving in a friendly culture environment based upon solid values (dare - share - care - be fair)
- Acting autonomously and belonging to motivated teams with good work-life balance
- Contributing to a company where sustainability, safety and well-being are key to our success