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    Audit Specialist

    Parexel
    2+ years
    Not Disclosed
    Remote - Europe
    10 Oct. 9, 2024
    Job Description
    Job Type: Remote 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

    Audit Specialist (Serbia or Lithuania)

    About Us: At Parexel, we are expanding our portfolio and are currently seeking an Audit Specialist to join our team in Serbia or Lithuania. Our Audit Specialists leverage their expertise to guide the preparation, management, and follow-up of Sponsor Audits and Regulatory Inspections effectively.

    Your Role: As an Audit Specialist, you will play a crucial role in ensuring that audits are conducted smoothly and to the highest standards, meeting both client and regulatory expectations.

    Key Responsibilities:

    • Collaborate with Sponsors, Parexel project teams, and Quality Assurance Management throughout the lifecycle of a Sponsor Audit Inspection (SAI).
    • Conduct preparation meetings, assign tasks to internal departments, and gather necessary documentation for Sponsor confidentiality agreements.
    • Initiate and manage planning processes, including project plans with deadlines and milestones for effective SAI execution.
    • Ensure SAIs are conducted to high standards of client satisfaction and in compliance with regulatory requirements.
    • Build and maintain strong working relationships with both internal and external stakeholders.
    • Determine the most suitable settings for hosting SAIs based on specific requirements.
    • Provide active support to the host during the SAI as needed.
    • Assist with audits and inspections of Non-Parexel facilities, such as investigator sites, supplier sites, and sponsor offices.
    • Ensure Technical Enterprise Tools (e.g., extranet, PMED, PMEX, Microsoft Teams) are properly configured, tested, and tailored to meet Sponsor needs.
    • Summarize quality events arising from Sponsor audits and related activities as requested.

    Skills and Qualifications:

    • Confidently and diplomatically address sensitive issues in a professional manner.
    • Excellent interpersonal, verbal, and written communication skills.
    • Proficiency in Microsoft applications and a willingness to learn internal systems.
    • Flexibility to adapt to changing priorities and unforeseen events.
    • Strong time management skills with the ability to follow up on multiple tasks and projects.
    • A positive team player with a proactive attitude.
    • Ability to work consistently in a fast-paced environment.

    Knowledge and Experience:

    • Significant experience in Quality Assurance, auditing, and clinical trial support.
    • Strong knowledge of GxP standards, industry regulations, and applicable regional requirements.
    • Proficient in MS Office applications (Teams, Word, Excel, Outlook).

    Education:

    • A degree in technology, biological sciences, pharmacy, or a related health discipline is preferred, or equivalent clinical research experience.
    • Strong command of written and spoken English, along with proficiency in the local language.

    Note: A background in pharmacovigilance is preferred for this position.

    If you're ready to make a meaningful impact in the field of clinical research and quality assurance, we encourage you to apply!

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