Location: Europe, Middle East & Africa-UK-England-Cambridge
Closing Date: 28 Oct 16
Type: Full Time
Salary (£): On Application
Clinical Trials Submissions Specialist PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...
Clinical Trials Submissions Specialist
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 14,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.
PPD is recruiting a Clinical Trials Submission Specialist for our Site Intelligence & Activation (SIA) department in the UK. This role can be based in any of our UK offices. The Country Approval Specialist will manage the preparation, review and coordination of Ethics Committee and Regulatory submission in the UK and will coordinate all activities to get investigational sites ready to enrol patients in our clinical trials.
• Preparation, reviewing and coordinating local ethics and regulatory submissions in alignment with global submission strategy
• Providing local regulatory strategy and advice
• Acting as a key contact on a country level for all submission related activities and provide oversight for projects
• Taking ownership of bringing qualified sites to the status of ‘ready to enrol’
• Draft, review and track contracts, utilising your legal and commercial acumen.
• Work with global project teams to provide them with contract and legal support of a high calibre to meet tight deadlines.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
• Additional tasks in line with business and department needs
This position is an office based role that can be located in our Cambridge, Winchester or Bellshill office and is available on a permanent or 12 month FTC basis
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