Clinical Study Manager (CSM)
My client is a young and successful biopharmaceutical company located in Germany, developing innovative therapies. They require Clinical Study Manager CSM to be based near Frankfurt.
- Oversight on project timelines, quality and deliverables
- Support in preparation of regular status reports to the management
- Contribution to and review of study documents, e.g. synopsis, investigator’s brochure, patient informed consent documents, site instruction manuals etc.
- Co-ordination of project activities with other departments
- Handling of contract negotiations with trial sites/ pharmacies/ local labs in Germany
- Preparation and conduct of project trainings
- Organisation and conduct of team meetings
- Organisation and participation in investigator meetings
- Generation of a project database
- Processing of all relevant issues of the national and international ethics committees and regulatory authorities in adherence to the timelines
- Effective internal and external project communication
- Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
- Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP)
- Minimum 2 years of experience in project management, regulatory submissions, monitoring of clinical trials or clinical trial assistance
- Refined colloquial and correspondence skills in German (written and spoken)
- Fluent in English (written and spoken)
- Experience in usual software (Word, Excel, Power Point, MS Project)
- Ready to take over responsibility, pro-active way of working
- Able to motivate and lead a team / used to work in a team
- Excellent organisational skills
Please contact Emma Hobbs +44 1483 397070 firstname.lastname@example.org to discuss this position in more detail.