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Reg & Start Up Spec 1

1-2 years
Not Disclosed
10 Dec. 19, 2024
Job Description
Job Type: Full Time Remote 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: Reg & Start Up Specialist 1
Location: Bangalore, India (Remote)
Job Type: Full-Time
End Date: 12/24/2024

Job Overview:
The Reg & Start Up Specialist will collaborate with the strategic CSS in creating and distributing various documents and system builds to drive efficient study start-up activities globally.

Responsibilities:

  • Survey Build: Creation of electronic surveys based on required study documents.
  • Package Build: Prepare and build electronic packages for sites, including essential and regulatory documents.
  • Query Tracking: Track queries from regulatory bodies within the electronic system.
  • ICF Build: Create Informed Consent Form (ICF) templates based on country-specific requirements.
  • Essential Document Review: Review essential documents against checklists in compliance with country regulations.
  • Transactional Activities: Complete tasks such as Clinical Study Report (CSR) creation and Trial Master File oversight.

Qualifications:

  • Bachelor’s Degree in healthcare or a scientific field (preferred) or equivalent experience.
  • Proficient in Excel.
  • 1-2 years of clinical research experience and at least 1 year in study start-up.
  • Experience with ICF review and essential document review.
  • Familiarity with IRB/IEC and regulatory submissions.
  • Prior experience with Vault Clinical (or similar tracking system).

Company Overview:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We aim to accelerate the development and commercialization of medical treatments to improve patient outcomes worldwide.

Job Function: Clinical Operations
Role: Full-Time