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 execution 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 (Apply online only) in all correspondence.

Please note: 

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

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