Regulatory and Start Up Specialist (FSP) at IQVIA

  • Published date: March 29, 2024
  • Category: Administrative & Office
    • Location: Nairobi, Nairobi
  • Jop type:
  • Salary: Ksh Not mentioned
  • Company name: Jobs in Kenya

Job Description


Job Overview:



  • 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.

  • Prepare site regulatory documents, reviewing for completeness and accuracy.

  • Perform admissions of regulatory documents.

  • 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.

  • Perform quality control of documents provided by sites.

  • Inform team members of completion of regulatory and contractual documents for individual sites.


Requirements:



  • Bachelor’s Degree in life sciences or a related field

  • 3 years clinical research experience, including 1 year experience in a leadership capacity or equivalent combination of education, training, and 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.



 

Method of Application


Interested and qualified? Go to IQVIA on jobs.iqvia.com to apply

 

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