Clinical Data Manager (f/m/x)
Medical Products Europe

Company:

Our client is an international start up company based in the USA. The company has developed new approach to treat a widespread cardiac disease. The international team started the clinical phase for the active implantable medical device two years ago and is now expanding its study efforts to further evaluate the effectiveness of the therapy parallel to obtaining authorization for the CE Mark and FDA. We are looking for a fulltime freelance expert in clinical data management to manage the existing data and data from the next multicentric clinical study which is planned to be conducted across Europe over the next two years.

The Position:

• Responsible for the clinical data management including the introduction of an electronic data management system to replace the current paper-based one
• Secure data quality in compliance with FDA and CE guidelines through the implementation of reliable processes including verification and validation
• Supervise the study centers by new data entries and initiating trainings to improve the quality of data entry
• Migrate the existing paper CRF and Excel data into the digital EDC system until an eCRF system is well established
• Being the internal and external contact person for the clinical data management including maintenance
• Ensuring appropriate communication and accessibility of data both internally and externally (e.g. to a statistician)
• There is the potential to expand responsibilities within the team (e.g. technical on-site support) if qualifications and time permit

Your Profile:

• Experience with clinical data management in an international, mutlicentric environment or comparable challenges within the medical device industry
• Detailed knowledge of the database and the data management tools you are going to implement[/li)
• Knowledge of Good Clinical Practice and clinical research, preferably in the field of medical devices
• Reliable and flexible personality will be required for success in an ever-changing, international start up environment
• Developed communication skills to effectively correspond with all levels of external partners and within the company
• Very good English both spoken and written. Other languages are an advantage, for example German or an Eastern European language
• Consistent track record and loyalty towards your previous employers or projects

Your Opportunity:

• You are working directly for our customer in an innovative, international and multi-cultural environment within an excellent perspective
• A very rare opportunity not only to secure stock options, but to gain a foot-hold into the international start up business
• Perfect conditions for a future participation in an expanding international company