Clinical Submission Specialist - UK
PPD
Bellshill, United Kingdom, United Kingdom
4d ago

Clinical Trial Start-Up Submission Specialist

PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services.

Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.

We have an exciting internal opportunity for you to join the Site, Intelligence & Activation (SIA) on a permanent basis.

As a Country Approval Specialist, you will manage the preparation, review and coordination of country submissions in the UK.

This is an office based position and can be based in Cambridge, Glasgow or Winchester office. Main duties and Responsibilities include :

  • Prepare, review and coordinate local submissions to Regulatory and Ethics Committee required for clinical trial site approval in alignment with global submission strategy
  • Provide local regulatory strategy and advice
  • Act as a key contact on a country level for all submission related activities and provide oversight for projects
  • Coordinate, under guidance, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines
  • Oversight of the trial set-up and responsible for liaising with other functional roles within the start-up team such as Feasibility Specialists, Contract Specialists, Clinical Research Associates and Project Assistants.
  • Qualifications

  • Ideally experience in a study start-up, or experience with, regulatory documents in a clinical setting
  • University degree in a health / science-related will be an advantage
  • Deep knowledge in UK and Ireland Clinical Research Legislation
  • Understanding of ICH-GCP
  • Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
  • Strong attention to detail
  • Customer focus
  • Effective communication and interpersonal skills
  • Good organizational and time management skills
  • Ability to work in a team or independently as required
  • Fluency in English both written and spoken
  • LI-EP1IndeedPPDEMEANW Additional Information
  • Requisition ID : 152932
  • Apply
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