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Regulatory Manager, Clinical Trials Regulatory Management- Home-Based, Emea

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: Clinical Trial Regulatory Manager
Location: [Location]
Company: IQVIA

Job Description

As a Clinical Trial Regulatory Manager (CTRM), you will provide regulatory support for complex clinical trial projects and programs, contributing to clinical trial submissions. Your responsibilities will involve independently preparing and reviewing regulatory documents, ensuring compliance with regulations and guidelines, and providing technical/scientific feedback on core scientific documentation.

Responsibilities

  • Act as a Clinical Trial Regulatory Manager (CTRM) for complex clinical trials, with the possibility of overseeing key customer projects.
  • Review core scientific documents and provide gap analysis feedback to customers.
  • Write scientific documents such as Investigational Medicinal Product Dossier (IMPD) and clinical trial justifications.
  • Plan and execute European centralized submissions and facilitate global country submissions for complex studies.
  • Support regulatory business development opportunities and contribute to Data Informed Protocol Assessments (DIPAs).
  • Ensure the timely completion of projects, adhering to agreed timelines, budgets, and deliverables.
  • Maintain accurate documentation in internal systems, databases, and project plans according to SOPs (customer and/or IQVIA).
  • Deliver regulatory training or presentations as required, both internally and externally.
  • Mentor junior colleagues and engage in knowledge sharing within the department.
  • Perform additional tasks as assigned by the Line Manager.

Required Knowledge, Skills, and Abilities

  • Solid understanding of clinical research regulations, directives, and guidance.
  • Comprehensive regulatory and technical expertise with the ability to resolve issues in a flexible and adaptable manner.
  • Strong ownership skills and the ability to lead meetings and initiatives.
  • Ability to manage multiple projects while maintaining quality and meeting timelines.
  • Experience in suggesting process improvements and revisions to SOPs.
  • Excellent mentoring and team collaboration skills.
  • Strong problem-solving abilities and a solutions-driven approach.
  • Proficient in MS Office applications and software tools.
  • Ability to build and maintain effective working relationships with clients, co-workers, and managers.

Minimum Required Education and Experience

  • Degree in a life science-related discipline or equivalent professional experience, plus at least 5 years of relevant experience. Alternatively, a high school diploma plus at least 9+ years of relevant experience.
  • EU-CTR knowledge and experience.
  • Experience with global CTA submissions.

Physical Requirements

  • Extensive use of telephone and face-to-face communication, requiring accurate speech perception.
  • Regular use of keyboard, involving repetitive finger motions.
  • Extended periods of sitting.
  • Some travel may be required.