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Regulatory And Start Up Admin

1+ years
Not Disclosed
10 Jan. 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Trial Submission Coordinator Support
Company: IQVIA
Location: [Insert Location]

Job Overview

As a Clinical Trial Submission Coordinator Support, you will assist the Clinical Trial Submission Coordinator (CTSC), Regulatory CTA SM, and GCO country teams with the initial and amendment submissions, as well as clinical trial notifications in the Clinical Trial Information System (CTIS). You will also track the progress of submissions and ensure the smooth flow of the submission process.

Essential Functions

  • Assist in managing study-specific submission documents and ensure proper collation for submission.
  • Perform document quality and completeness checks to ensure all required information is included.
  • Transfer submission packages to CTIS, perform the submission in CTIS, and handle submission archiving.
  • Maintain up-to-date tracking of submission status and related information in appropriate Clinical Trial Management Systems (CTMS).
  • Collaborate with the CTSC, Local Trial Managers, Site Managers, and the GCO country Local Submission Coordinator to ensure submission data is accurate and up-to-date throughout the trial phases.
  • Support submission coordination activities and track submission timelines and deliverables to ensure the trial progresses according to agreed milestones.
  • Review and manage CTIS entries for completeness and timely updates.
  • Assist CTSC, Regulatory CTA SM, CTM, and GTL with applicable CTIS support.
  • Provide an overview of submission, substantial amendment, and notification management metrics as required.

Qualifications

  • 1 year of clinical research experience, or an equivalent combination of education, training, and experience.

About IQVIA

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We create intelligent connections that accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.

Learn more at IQVIA Careers.