Do you have experience in designing, planning and conducting clinical trials within IVD or within Medical Devices? Are you available to work fulltime for one of the most successful biotech companies? Let's connect for this existing opportunity!
Our client is looking for a clinical project manager who could significantly contribute towards efficient/expedited launch of new or improved products. You will be accountable for the design, planning and conduct of clinical studies, including reporting results. You will be coordinating the efforts and activities of diverse internal and external stakeholders, ensuring compliance with organizational SOPs and all international regulations, while ensuring that all aspects of the clinical study are completed correctly and in a timely manner within budget. For this position, you will need to work independently and autonomously.
- Accountable for study design, strategy, planning (timeline and budget) for sponsored clinical studies, coordinating activities with stakeholders internally and externally and providing regular status reports
- Accountable for the development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs
- Accountable for managing and tracking of clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up internal and external communications for correction, troubleshooting, and prevention planning
- Coordinating and supervising clinical monitoring team
- Minimum 2-3 years working experience with in vitro diagnostic or Medical Devices company.
- Working experience in Clinical Affairs/Operations and experience with diagnostic or medical devices clinical studies
- Good understanding of project management
- Authoring clinical study documents e.g. Protocols, Investigator Brochure, Informed Consent Documents
- Proficient English oral and written communication
- Assignment for 12 months
- Working schedule: full time
- Remote working position with occasional travel in the office (Barcelona - Spain, Hilden - Germany, Manchester - UK, German Town - USA)
Existing right to work in Europe or USA required ( please read job spec in full before applying ).
Vacancy number: 17359