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Study Start Up Specialist - UK IQVIA Biotech

IQVIA LLC, Reading

Study Start Up Specialist - UK IQVIA Biotech

Salary not available. View on company website.

IQVIA LLC, Reading

  • Full time
  • Permanent
  • Remote working

Posted 2 weeks ago, 2 Oct | Get your application in now before you miss out!

Closing date: Closing date not specified

Job ref: bd00bf9f3743432f93c77f28133dd2a2

Location ref: Reading

Full Job Description

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, 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.
  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines.
  • Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • 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.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.

    Bachelor's Degree in life sciences or a related field
    • 3 years clinical research experience In-depth knowledge of clinical systems, procedures, and corporate standards. Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Knowledge of applicable regulatory requirements, including local regulations, SOPs and company's Corporate Standards. Understanding of regulated clinical trial environment and knowledge of drug development process.

    IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

Direct job link

https://www.jobs24.co.uk/job/study-start-up-specialist-uk-iqvia-biotech-127504138
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