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(Sr) Site Activation Specialist / Regulatory And Start Up Specialist

2+ 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: (Sr) Site Activation Specialist
Company: IQVIA
Location: Zagreb, Croatia (Hybrid)

Job Overview

Are you passionate about advancing clinical research? Join IQVIA Zagreb as a (Sr) Site Activation Specialist and become a part of a dynamic team making a meaningful impact in the clinical trials landscape. In this role, you will be responsible for ensuring the completion and accuracy of site documents, managing site readiness, and overseeing site activation activities. You will also handle clinical trial contracts, submissions to ethics committees (EC) and regulatory authorities (RA), and support investigator budget negotiations.

Key Responsibilities

  • Ensure site documents (such as questionnaires, CDAs, ICFs, and Investigator Pack releases) are complete and accurate.
  • Distribute documents to sites and internal project teams, tracking and following up on the approval and execution of essential documents.
  • Manage EDP collection and ensure sites are ready for enrollment activities.
  • Negotiate investigator budgets and manage the Clinical Trial Agreements (CTAs) for assigned sites.
  • Ensure timely submission of documents to Ethics Committees (ECs) and Regulatory Authorities (RAs) in Croatia and Slovenia (experience with Bosnia is a plus).

Qualifications

  • Bachelor’s degree in Life Sciences or a related field (preferred).
  • 2+ years of relevant clinical site activation experience, including managing trial contracts and submissions in Croatia and Slovenia (Bosnia experience is a plus).
  • Experience with Site ID is desirable but not required.
  • Proficiency in Croatian and English.
  • Based in Croatia with the flexibility to work from our Zagreb office or in a hybrid model.
  • A passion for long-term career growth within the Clinical Site Activation department.

About IQVIA

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

Learn more at IQVIA Careers.