Regulatory and Start-Up Specialist
IQVIA Holdings Inc.
Centurion, South Africa
17h ago

Centurion, South Africa

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and / or international regulations, standard operating procedures (SOPs), project requirements and contractual / budgetary guidelines.

May also include maintenance activities.

Qualifications

  • Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience;
  • or equivalent combination of education, training and experience.

  • 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Good negotiating and communication skills with ability to challenge, if applicable.
  • Effective communication, organizational, and interpersonal skills.
  • Ability to work independently and to effectively prioritize tasks.
  • Ability to manage multiple projects.
  • 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.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.

    The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our ,+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

    Report this job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Apply
    My Email
    By clicking on "Continue", I give neuvoo consent to process my data and to send me email alerts, as detailed in neuvoo's Privacy Policy . I may withdraw my consent or unsubscribe at any time.
    Continue
    Application form