Excellent opportunity for a Clinical Operations Manager to a multinational Medical Devices company based in Frankfurt, Germany. The role is responsible for managing clinical operations for the EMEA region. This includes all clinical trials conducted outside of the US.
Overview of your responsibilities (full job description available on request)
- Hire and train new employees and contractors, as needed.
- Manage in-house clinical, field clinical, and administrative staff daily.
- Supervise and train the Clinical Research Associates (CRAs), Sr. CRAs and Clinical Trial Assistants
- Work with Clinical Data Management to manage the study recruitment and develop enrollment strategies
- Appraisal of staff; overseeing day-to-day work;
- Support Site Qualifications, training and initiation visits for new clinical trial sites
- Ensure site regulatory documentation, EC requirements (local and central), and CA requirements are followed.
Knowledge, Skills and Experience Required for the Role:
- Bachelor's degree in life sciences or related field
- 5 years clinical research experience including atleast 2 years clinical operations management experience
- In-depth knowledge of medical device clinical research regulatory requirements; i.e., ISO 14155, MEDDEV 2.7,
- Medical Device Vigilance MEDDEV 2.12-1, MDCG 2020-10/1
- Fluent German and English speaker
For a confidential discussion and more information on the role contact Courtney Russell
+353 (0) 71 9108062