Instagram
youtube
Facebook

Reg & Start Up Spec 1

1-2 years
Not Disclosed
10 Dec. 5, 2024
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 Description: Clinical Study Start-Up Specialist

Job Overview:
The Clinical Study Start-Up Specialist will collaborate with the strategic Clinical Study Services (CSS) team to create and distribute various documents and system builds, driving effective and efficient global study start-up activities.

Responsibilities:
Key responsibilities include, but are not limited to:

  • Survey Build (Key Study Document List): Create electronic survey builds based on required documents needed for studies.
  • Package Build: Prepare and build electronic packages for study sites, including essential documents, regulatory documents, and more.
  • Query Tracking Process: Track queries issued by regulatory bodies within the electronic system.
  • Informed Consent Form (ICF) Build: Create ICF templates based on country-specific requirements provided by affiliates.
  • Essential Document Review: Review essential documents according to the checklist for compliance with country regulations.
  • Transactional Activities Completion: Handle various defined transactional activities such as Clinical Study Report (CSR) and Trial Master File Oversight.

Qualifications:

  • Bachelor's degree in healthcare or a scientific field, or equivalent years of experience.
  • Competent use of Excel.
  • Minimum 1-2 years of clinical research experience, with at least 1+ years in study start-up.
  • Experience in Informed Consent Form (ICF) review and essential document review.
  • Experience working with IRB/IEC and competent authority submissions and approvals.
  • Prior experience with Vault Clinical (or similar tracking system).

About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com