Reg & Start Up Spec 1

IQVIA

Vienna, Austria
Country level regulatory tasks
Investigative site spoc
Adherence to sops and wis
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

Job Summary

  • 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.
  • 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.
  • 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.

Matching Summary

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.

Skills & Requirements

Must-have

  • Country level regulatory tasks
  • Investigative site SPOC
  • Adherence to SOPs and WIs
  • Site regulatory document preparation
  • Internal systems and database maintenance
  • Quality control of site documents

Nice-to-have

  • Local expertise for project planning
  • Direct contact with sponsors
  • Proactive monitoring and contingency planning

Key Requirements

  • 1 year clinical research experience
  • Equivalent combination of education, training and experience

Work Rights

Not specified

Tailored Resume

Cover Letter