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Fsp - Sr. Regulatory & Start Up Specialist

Iqvia
IQVIA
3+ years
Not Disclosed
9 Nov. 23, 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: Regulatory & Start-Up Specialist

Job Overview

The Regulatory & Start-Up Specialist is responsible for performing country-level tasks associated with Site Activation (SA) activities. This includes ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. The role may also involve maintenance activities throughout the project lifecycle.


Essential Functions

  1. Single Point of Contact (SPOC) Role

    • Serve as the Single Point of Contact for assigned studies, working with investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
    • Ensure adherence to SOPs, Work Instructions (WIs), and quality standards for deliverables and project timelines.
  2. Site Activation & Start-Up Activities

    • Perform site activation tasks according to applicable regulations, SOPs, and work instructions.
    • Distribute completed documents to sites and internal project teams, ensuring all required regulatory documents are properly prepared and accurate.
  3. Regulatory Documentation Management

    • Review and ensure the accuracy of site regulatory documents, ensuring completeness and compliance with project requirements.
    • Maintain accurate records in internal systems, databases, and tracking tools with project-specific information.
  4. Project Planning & Timeline Management

    • Collaborate with the team to establish and review project planning and timelines, ensuring monitoring measures are in place.
    • Implement contingency plans as needed and track the progress of site approvals and document execution, including regulatory, ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) releases.
  5. Local Expertise & Quality Control

    • Provide local regulatory expertise to SAMs and project teams during initial and ongoing project planning.
    • Perform quality control of documents provided by sites to ensure they meet regulatory and project standards.
  6. Sponsor Communication

    • May have direct contact with sponsors for specific initiatives, providing timely updates and addressing any concerns.

Qualifications

  • Education:

    • Bachelor’s Degree in life sciences or a related field.
  • Experience:

    • A minimum of 3+ years of clinical research experience in the regulatory field within Argentina, including:
      • Local regulatory submissions
      • Informed Consent Form (ICF) customization
      • Presentations to ethics committees and ANMAT
  • Skills and Competencies:

    • Fluent in English with strong written and oral communication skills.
    • Ability to work independently and prioritize tasks effectively.
    • Strong attention to detail and quality control.
    • Knowledge of local regulatory guidelines, GCP/ICH, and the clinical trial process.

This role is ideal for a professional looking to apply their regulatory expertise in a dynamic and supportive environment, ensuring compliance and successful site activation across clinical research studies.