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    Regulatory And Start Up Specialist - Romania

    Iqvia
    3-5 years
    Not Disclosed
    Romania
    11 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

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    Job Description: Site Activation Specialist (Fluent in English and Romanian)

    Job Overview

    Perform country-level tasks related to Site Activation (SA) activities in compliance with local/international regulations, SOPs, project requirements, and contractual/budgetary guidelines. This role may also include site maintenance activities.

    Location: Home-Based
    Language Requirement: Fluency in English and Romanian

    Essential Functions

    1. Coordination and Communication

      • Serve as the Single Point of Contact (SPOC) for assigned studies, liaising with investigative sites, Site Activation Managers (SAMs), Project Management teams, and other departments as needed.

    2. Regulatory and Site Activation Activities

      • Perform start-up and site activation tasks in accordance with applicable regulations, SOPs, and work instructions.
      • Prepare and review site regulatory documents for accuracy and completeness.
      • Distribute finalized documents to sites and internal project teams.

    3. Project Management and Planning

      • Review, establish, and agree on project plans and timelines, ensuring adherence to monitoring measures and implementing contingency plans as necessary.
      • Inform team members about the completion status of regulatory and contractual documents for individual sites.

    4. Tracking and Reporting

      • Maintain accurate information in internal systems, databases, and tracking tools for project-specific activities.
      • Review, track, and follow up on progress, approvals, and execution of key documents (e.g., regulatory, ethics, ICFs, Investigator Pack release).

    5. Quality and Compliance

      • Conduct quality control of site-provided documents to ensure adherence to regulations and company standards.
      • Provide feedback to management on site performance metrics.
      • Ensure compliance with GCP/ICH guidelines and local regulatory requirements.

    6. Local Expertise and Support

      • Provide local regulatory expertise to SAMs and project teams during initial and ongoing project planning.
      • Support the review and resolution of local regulatory challenges.

    7. Client and Sponsor Interaction

      • May directly interact with sponsors on specific initiatives as required.

    Qualifications

    • Education and Experience:

      • Bachelor’s degree in Life Sciences or a related field.
      • Minimum 3 years of clinical research or related experience (or equivalent combination of education, training, and experience).

    • Skills and Competencies:

      • Strong communication, organizational, and interpersonal skills.
      • Ability to work independently and prioritize tasks effectively.
      • Proven ability to manage multiple projects concurrently.
      • Knowledge of GCP/ICH guidelines, regulatory requirements, and SOPs.
      • Familiarity with the regulated clinical trial environment and drug development processes.

    • Technical Knowledge:

      • Understanding of local regulatory requirements and company standards.
      • Proficiency in tracking tools, databases, and internal systems.

    • Languages:

      • Fluency in English and Romanian is mandatory.

    Key Attributes

    • Strong attention to detail and ability to adapt to a dynamic regulatory environment.
    • Collaborative mindset to establish and maintain effective working relationships with coworkers, managers, and clients.

    Join our team to play a vital role in facilitating impactful clinical research projects while ensuring adherence to global regulatory standards.

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