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    Regulatory And Start Up Manager (Com) - Austria

    Iqvia
    7+ years
    Not Disclosed
    Vienna
    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: Site Activation and Maintenance Manager (12-Month Fixed Term)
    Company: IQVIA
    Location: Vienna, Austria (Hybrid Capacity)

    Job Overview

    As the Site Activation and Maintenance Manager, you will oversee and manage the delivery of all site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes handling pre-award activities, as well as overseeing the scope of work, budget, and resources. The position is a 12-month fixed-term role with the potential for extension. Applicants must be based in Vienna as in-office presence is required in a hybrid capacity. In addition to RSU experience, familiarity with budgets and site contracts is essential.

    Essential Functions

    • Oversee site activation, including pre-award and bid defense activities, and/or maintenance for assigned projects in line with the RSU site activation strategy, ensuring project timelines are met.
    • Develop, implement, and maintain the Management Plan based on the Scope of Work and Project Plan, resolving any project-related issues as needed.
    • Facilitate collaboration between Regulatory & Site Activation teams, ensuring effective communication with regions and countries to meet project scope and compliance with the RSU Management Plan.
    • Create and/or review technical and administrative documents to support business development and study initiation/maintenance, while ensuring compliance with regulatory requirements.
    • Guide and oversee multi-regional and multi-protocol programs during startup and maintenance phases, acting as an integral member of the study management team.
    • Define regulatory strategy and expectations for submissions and authorizations, identifying regulatory challenges and providing solutions.
    • Analyze the regulatory landscape and contribute to the collection, interpretation, and dissemination of regulatory intelligence for assigned studies.
    • Manage the operational strategy for maintaining clinical study approvals, authorizations, and the review/negotiation of contracts and essential documents.
    • Work with Quality Management to ensure adherence to quality standards during site activation or maintenance.
    • Mentor and coach colleagues, ensuring accurate completion and maintenance of internal systems (CTMS), databases, tracking tools, timelines, and project plans.
    • Develop and maintain long-term relationships with key IQVIA customers and deliver presentations/training to clients, colleagues, and professional bodies.
    • Assist in monthly study budget planning and reviews.

    Qualifications

    • Bachelor’s Degree in Life Sciences or related field.
    • Minimum 7 years of relevant experience in a scientific or clinical environment, with demonstrable experience in international roles.
    • Strong negotiation and communication skills, with the ability to challenge when necessary.
    • Excellent interpersonal skills and a strong team player.
    • Proven ability to manage complex projects and deliver results on time and to the required quality standards.
    • Deep understanding of the regulated clinical trial environment and the drug development process.
    • Proficiency in using systems and technology to achieve work objectives.
    • Strong regulatory and/or technical writing skills.
    • Thorough knowledge of GCP, ICH guidelines, and applicable regulatory guidelines.
    • Effective leadership, coaching, and mentoring skills.
    • Exceptional organizational, planning, and decision-making abilities.
    • Strong study financial management skills and the ability to balance competing priorities.

    About IQVIA

    IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We drive intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.

    Learn more at IQVIA Careers.

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