Country Study Start Up Specialist
CK Clinical are recruiting for a Country Study Start Up Specialist to join a global bio-pharmaceutical company at their site based in Welwyn Garden City, Hertfordshire on a 12 month contract basis.
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 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.
- 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 Andy on 01438 842966 or email firstname.lastname@example.org, quoting job reference 48684.
It is essential that applicants hold entitlement to work in the UK.