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    Regulatory And Start Up Manager - Turkey

    Iqvia
    0-2 years
    Not Disclosed
    Istanbul
    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 looking for an SSU Study Start-Up Manager to manage and support the clinical trial start-up process, ensuring that all activities are completed on time and in compliance with regulatory and quality standards. This position will be responsible for overseeing local submission packages, working closely with local IRBs/IECs, Health Authorities, and collaborating with cross-functional teams to ensure smooth execution from country allocation to Green Light.

    Accountabilities

    • Collaborate with the SSU Study Start-Up Team Lead, SSO Country/Cluster Head Portfolio, and global study teams to ensure timely and accurate execution of SSU activities in alignment with country commitments.
    • Oversee start-up activities from country allocation to the Green Light milestone in assigned projects, ensuring all tasks are completed on time.
    • Work closely with local IRBs/IECs and Health Authorities, ensuring timely preparation and submission of documentation.
    • Coordinate local submission packages for IRB/IEC, CTA Hub (Europe: EU-CTR), and Health Authorities, including subsequent amendments, IBs, DSURs, and CSRs.
    • Manage responses to deficiency letters, collaborating with local and global stakeholders to resolve issues promptly.
    • Monitor reportable events and notifications to IRBs/IECs and Health Authorities as needed.
    • Ensure timely and accurate completion of country TMF documents to ensure inspection readiness.
    • Adhere to financial standards, prevailing legislation, ICH/GCP guidelines, IRB/IEC, Health Authority regulations, and SOP requirements.
    • Implement efficient processes for SSU activities, focusing on continuous improvement.
    • Support study feasibility in collaboration with the Feasibility Manager, Site Partnership Manager, and the global study team.
    • Lead site selection activities in collaboration with the Portfolio Team Lead and Clinical Project Manager (CPM).
    • Oversee local vendor selection and performance as necessary in satellite countries.
    • Serve as the main contact for quality and compliance issues during the SSU phase, escalating when necessary.
    • Ensure that sites are prepared for Green Light, and all documentation is in place for drug release.
    • Responsible for reviewing and signing off on the site "Green Light."
    • Lead the local SSU team in achieving start-up timelines and quality execution, proposing corrective actions as needed.
    • Lead local SSU team meetings and participate in global study team meetings, ensuring alignment on progress and challenges.
    • Develop country-specific 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.
    • Experience in clinical research, particularly in SSU activities, regulatory submissions, and project management.
    • Strong understanding of local and international regulations, ICH/GCP guidelines, and financial standards in clinical trials.
    • Ability to manage multiple tasks while adhering to project timelines and quality standards.
    • Proven leadership abilities and strong interpersonal skills to effectively manage teams and collaborate with stakeholders.

    About IQVIA

    IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We connect the world’s healthcare data, delivering insights and helping accelerate the development of innovative medical treatments.

    Learn more at IQVIA Careers.

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