•Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications
•Perform quality checks on submission documents and site essential documents
•Prepare and approve informed consent forms
•Review pertinent regulations to develop proactive solutions to start-up issues and challenges
•Present during bid defenses, general capabilities meetings, and audits.
•Line manage the regulatory submissions team.
More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience; Knowledge and experience with Clinical Trial Applications within Europe; and Strong oral and written communication skills. Fluency in English and local language.
This position can offer line management responsibility however this will not be from day one as the project management is the focus on the role. The line management will come in time, possibly after initial training, but this will be in addition to the project management which is the focus of the role.