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    Regulatory And Start Up Manager - Poland

    Iqvia
    3+ years
    Not Disclosed
    Warsaw
    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: SSU Study Start-Up Manager
    Company: IQVIA
    Location: [Insert Location]

    Job Overview

    We are seeking a SSU Study Start-Up Manager to support and drive study start-up activities for assigned projects, ensuring timely and high-quality execution in compliance with local and international regulations. This role involves close collaboration with internal teams, local IRBs/IECs, and Health Authorities to prepare and finalize submission packages, manage timelines, and ensure a smooth start-up process.

    Accountabilities

    • Collaborate with SSU Study Start-Up Team Lead, SSO Country/Cluster Head Portfolio, SSOP Portfolio Team Leads, and global study teams to ensure SSU timelines and deliverables meet country commitments.
    • Accountable for timely start-up activities from country allocation to achieving the Green Light milestone (ready to initiate site milestone) in assigned projects.
    • Ensure collaboration with local IRBs/IECs and Health Authorities, preparing necessary documentation and obtaining approvals for study start-up.
    • Prepare and finalize local submission packages for submission to IRBs/IECs, CTA Hub (Europe: EU-CTR), and Health Authorities, including subsequent amendments, IBs, DSURs, and CSRs.
    • Coordinate responses to deficiency letters from regulatory bodies, collaborating closely with local and global stakeholders.
    • Manage reportable events and notifications to IRBs/IECs and Health Authorities as necessary.
    • Ensure accuracy and quality of country TMF documents in study start-up, ensuring TMF inspection readiness.
    • Adhere to financial standards, ICH/GCP, IRB/IEC, Health Authority regulations, and SOP requirements during study start-up.
    • Implement innovative and efficient processes to improve study start-up timelines and quality.
    • Support study feasibility in collaboration with Feasibility Manager, Site Partnership Manager, and global study team.
    • Lead site selection in collaboration with Portfolio Team Lead and Clinical Project Manager (CPM) if already assigned.
    • Oversee local vendor selection and performance in satellite countries as needed.
    • Act as the main contact for quality/compliance issues during SSU phase, escalating as necessary.
    • Ensure sites are ready for Green Light, with all documentation in place for drug release.
    • Review and sign off on site Green Light, ensuring all documentation and approvals are in place.
    • Oversee local SSU team activities to achieve study start-up timelines and quality execution, proposing corrective actions as needed.
    • Lead and chair local SSU team meetings, ensuring alignment with global study team goals.
    • Lead the development of country site initiation and patient enrollment plans in collaboration with SSU CRA, CPM, and SSU Lead.

    Qualifications

    • Bachelor's Degree in Life Sciences or a related field.
    • 3+ years of clinical research experience in study start-up, regulatory submissions, and contract negotiations.
    • In-depth knowledge of clinical systems, procedures, and corporate standards.
    • Strong negotiation, communication, and organizational skills.
    • Ability to work independently and manage multiple tasks with attention to timelines and quality.
    • Knowledge of GCP/ICH and applicable regulatory guidelines.
    • Proven ability to establish and maintain effective working relationships with colleagues, clients, and external stakeholders.

    About IQVIA

    IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments.

    Learn more at IQVIA Careers.

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