Country Study Start Up Specialist

  • Salary: £350 per day
  • REF Number: 00049590
  • Consultant: Stephen Lord
  • Contact: 01246 457738
  • Date Published: 11.01.2021
  • Sector: Non-Specific
  • Location: Welwyn Garden City,
  • Discipline:

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.

Company: 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 UpSpecialist 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.

Otherresponsibilities 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 ethicscommittees' 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.

Apply: For more information or to apply for this Country Study Start Up Specialist, please contact Steve on 01246 457738 or email slord@ckclinical.co.uk, quoting job reference 49590.

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

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