IQVIA

Clinical Associate – Regulatory Submissions

IQVIA

full-time

Posted on:

Location Type: Hybrid

Location: Vienna • Austria

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About the role

  • 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.
  • Work and lead complex projects under general supervision.
  • Serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.
  • Ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.
  • Prepare submission documents and submit to regulatory bodies.
  • Perform feasibility, site ID, 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 documents and review for completeness and accuracy.

Requirements

  • B Sc degree in Health Sciences or related field
  • 1 - 3 years' relevant clinical research experience, specifically in submissions.
  • Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent adaptation for DACH regions.
  • Experience in Site Contract negotiations with DACH sites.
  • Experience in medical device submissions is beneficial.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
Benefits
  • No specified benefits mentioned

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical researchsubmissionssite activationfeasibilitysite identificationsite contract negotiationsmedical device submissionsregulatory submissionsproject managementquality assurance
Soft skills
leadershipcommunicationorganizational skillsattention to detailproblem-solving
Certifications
B Sc degree in Health Sciences