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iqvia/iqvia1 day ago

Regulatory and Start Up Specialist - UK

Remote · London, England, United Kingdom or Reading, England, United Kingdom

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Site activation and regulatory start-up responsibilities at country level, including serving as SPOC for investigative sites, Site Activation Manager, and project teams; prepare and review regulatory documents (ethics, IC_forms, Investigator Pack), ensure SOP/WI compliance and maintain project timelines; manage document distribution, data tracking, and local regulatory input; provide local expertise during planning and timelines, perform quality control of site documents, and liaise with sponsors as needed. Requires a Bachelor’s degree in life sciences, 3 years of relevant clinical research experience, knowledge of GCP/ICH and regulatory guidelines, and strong cross-functional collaboration skills. Home-based opportunity in the UK (London or Reading area).

Required Qualifications

  • Bachelor’s Degree in life sciences or a related field
  • 3 years’ clinical research or other relevant experience
  • In-depth knowledge of clinical systems, procedures, and corporate standards
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Understanding of regulated clinical trial environment and knowledge of drug development process
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

Desired Qualifications

  • Bachelor’s Degree in life sciences or a related field
  • 3 years’ clinical research or other relevant experience
  • In-depth knowledge of clinical systems, procedures, and corporate standards
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Understanding of regulated clinical trial environment and knowledge of drug development process
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
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iqvia/iqvia

Regulatory and Start Up Specialist - UK

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