Study Start-Up Specialist

CK Group are recruiting for a Study Start-Up Specialist, to join a leading provider of advanced analytics, research and technology solutions to the life sciences industry, on an inside IR35 contract basis, until 31/12/2025.


Salary:

Competitive


Study Start-Up Specialist Role:

• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, working with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Distribute completed documents to sites and internal project team members.
• Review, track and follow up the progress, the approval and of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

Your Background:

• Bachelor's Degree in life sciences or a related field.
• 3 years' clinical research or other relevant experience.
• Experience in study start-up and site activation activities.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

Company:

Our client offers research services and technology solutions in the life sciences industry. With just under 100,000 employees, the company has operations in over 90 countries worldwide. Our client s ambitions involve optimising results of innovations using artificial intelligence. They believe in utilising data collected to the maximum rather than focussing on gathering lots of information: they use artificial intelligence to do this.


Location:

Fully remote


Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 143 070 in all correspondence.


Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

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