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Reg & Start Up Spec 1

1-2 years
Not Disclosed
10 Dec. 20, 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 Opening: Reg & Start Up Specialist 1 - Clinical Operations

Job Type: Full-Time
Job Location: Remote (Bangalore, India)
End Date: 12/24/2024

Job Overview:
We are looking for a Reg & Start Up Specialist 1 to collaborate with the strategic CSS in creating and distributing various documents and system builds to drive effective and efficient study start-up activities globally.

Responsibilities:
Key responsibilities include but are not limited to:

  • Survey Build: Creation of electronic surveys based on the required documents needed for study.
  • Package Build: Prepare and build electronic packages for sites, including essential and regulatory documents.
  • Query Tracking Process: Track queries issued by regulatory bodies within the electronic system.
  • Informed Consent Form (ICF) Build: Create ICF templates based on country requirements.
  • Essential Document Review: Review essential documents against checklists according to country regulations.
  • Completion of Defined Activities: Support with other activities like Clinical Study Report (CSR) and Trial Master File Oversight.

Qualifications:

  • Education: Bachelor's degree in a healthcare or scientific field is highly preferred, or equivalent years of experience.
  • Skills: Proficient in Excel.
  • Experience: Minimum of 1-2 years in clinical research with at least 1 year of study start-up experience.
  • Experience with ICF review and essential document review.
  • Experience with IRB/IEC and competent authority submissions and approvals.
  • Prior experience with Vault Clinical or similar tracking systems.

About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We accelerate the development and commercialization of innovative medical treatments to improve patient outcomes globally.

How to Apply:
Learn more and apply at IQVIA Careers.