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Country Study Start Up Specialist

Hertfordshire   •  Contract/Temporary, Full time

CK Clinical are recruiting for a Country Study Start Up Specialist to join a global bio-pharmaceutical company. The role will be remote based initially, although they would want candidates to visit their site based in Welwyn Garden City, once the situation allows travel. This would be for an initial 12 month period.

This company is one of the world\'s largest biotech companies which is a leading provider of both cancer treatments and in vitro diagnostics.

Country Study Start Up Specialist Role:
As the Country SSUS you will be responsible for all the SSU-related activities in the UK, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research colleagues and stakeholders.

Other responsibilities include to:

  • Ensure compliance with local regulations and internal procedures.
  • Execute all start-up activities prior to site activation on assigned studies.
  • Prepare country level Informed Consent Form (ICF) and obtain ethics committees\' and local regulatory authorities\' approval.
  • Prepare ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities.

Your Background:

  • University degree in a medical/science field.
  • Proven project management or study start up experience within pharma.
  • Must be able to perform SSU activities unsupervised.
  • Good knowledge of ICH-GCP and other relevant regulations for starting clinical trials in the UK.

Quote job reference 49590.

It is essential that applicants hold entitlement to work in the UK.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Stephen Lord
  • Phone: 01246 457722
  • Reference: 49590
  • Posted: 11th January 2021
  • Expires: 8th February 2021

CK Group

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