Clinical Project Manager
TFS, Sweden
Job Description
Through this exciting opportunity you have the chance to join a dermatology company in Uppsala, being employed by TFS and fully outsourced to our client who has the whole product chain from research and development to production and marketing.
Our client is offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged.
The role includes:
• Participate in/co-ordinate the development of clinical documents such as study protocols, investigator brochures/Report of Prior Investigation and study reports
• Participate in the development of clinical documentation to support regulatory submissions and reply to questions from regulatory authorities.
• Participate in the development of risk analysis for products in development
• Manage the clinical scope of study preparation and conduct
• May serve as the primary contact with CRO and act as team leader of the study working group
• Manage clinical risk analysis for the scope of the clinical study
• Represent Clinical Development in project teams In addition to the assignment the following tasks will or may occur:
• Participate in the development and improvement of working instructions and routines pation in the development and improvement of working instructions and routines
Requirements
Basic requirements:
- Education Requirements: University degree in Biology, Chemistry, Pharmacy, or Medicine; preferably MSc or MD. PhD is meriting.
- 5-8 years of work experience
- Experience in doing presentations to a scientific audience.
- Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports
- Thorough knowledge in Good Clinical Practice
- Clinical study execution Experience as clinical project manager of clinical studies in major market(s) such as EU
- Courage and willingness to learn and work with new things
- Flexible to changes
Wishful mindset:
We are conducting interviews on an ongoing basis so please apply today if you want to know more about this opportunity.