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Study Start Up & Regulatory Director - Germany

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  • Study Start Up & Regulatory Director - Germany
    Want to be one lead the Study Start Up department of a leading CRO?
    Looking to work for a CRO that cares about the quality of service and not just all about money?
    Interested in having the flexibility to work from home a few days per week?

    Job type: Permanent
    Location: Munich or Langenfeld with some home working
    Salary: Flexible
    Reference Number: J23912

    My client is a full- service clinical research organisation, providing the full range of Phase I-IV clinical development services for the world's pharmaceutical, biotech and medical device industries. This organisation has business that spans across six continents, and are looking to strengthen their Ethics and regulatory department in the UK.
    Job Description:
    As a leading member of the Study Start Up team you will cover a wide variety of therapeutic areas and phases.
    - Develop and implement comprehensive global strategy
    - Leading projects regarding clinical trial submissions to Competent Authorities, Local and Central Ethics Committees.
    - Have oversight and input into major SSU projects
    - Line managing a team of 10-15 staff
    - Bid defences (chairing/leading)
    Job Requirements:
    - Fluent English and German
    - 8+ years relevant experience
    - Strong line Management and leadership experience
    - Ethics Committee submission experience in multiple countries
    - Global submissions experience
    If you are interested in this role please email your CV to or call Adam Taher on (0) to discuss further.
    Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.
    Key words: Regulatory, Regulatory Affairs, SSU, Study Start Up, Director, Regulatory Affairs Director Clinical, CTA, Ethics Committee, Germany, Munich, Cologne, Dusseldorf, home working, Competent Authorities, Site Activation, Clinical Operations, Clinical Operations Director


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