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Clinical Start-up Specialist - 6 month contract

Business Type: Pharmaceutical Company
Job Type: Clinical Research, Clinical Operations, Clinical Study- Trials
Job Level: Experienced (non manager)
Position: Contract
Location: Hertfordshire
Reference: sd-clinicalstartup
Closing Date: 08/05/19
Job Details:
Clinical Start-up Specialist - 6 month contract

A fantastic opportunity has become available for a Clinical Start-up Specialist to join a top pharmaceutical company based in Hertfordshire for a 6-month contract.

As a Clinical Start-up Specialist you will:
*Coordinate guide and assist with all start-up activities prior to site activation, including but not limited to:
-Site Informed Consent Form
-Ethics Committee information
-Clinical Trial Health Authority application and regulatory submission process
-Localize global Informed Consent Form
*Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements
*Review, analyze and collate metrics to ensure processes are in place
*Ensure all start up information & requirements are kept up to date
*Assist with label preparation and approval
*Liaise and collaborate with relevant authorities
*Assist with identification and tracking of new sites in collaboration with CSMs
*Provide reports to local study teams on overall site performance
*Negotiate contracts and study budgets
*Liaise with management / Country Study Managers
*Responsible for ensuring all local safety reporting

The company is looking for someone who has experience in:
*Managing national UK ethics submissions and costing negotiations
*Experience with start-up activities- conducting site selection
*UK experience
*Internal and external stakeholder engagement
*Strong experience in setting up UK clinical trials

If you are interested in this opportunity and wish to discuss further details about the role, please contact Sabrina Deo at or 0121 616 3471/ 07824452641

Clinical, project management, pharmaceutical, CRO, Hertfordshire, contract, freelancer, study budgets, stakeholders, trials, submissions, planning, safety reporting, authorities, UK

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Posted: 10/04/2019 | NPJ Ref: 233686
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