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    Regulatory & Start-Up Lead

    Iqvia
    3+ years
    Not Disclosed
    Taipei
    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
    Company: IQVIA
    Location: [Insert Location]

    Job Overview

    As a Site Activation and Maintenance Manager, you will lead and manage the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes overseeing pre-award activities, managing scope of work, budget, and resources to ensure project timelines are met.

    Essential Functions

    • Oversee the execution of site activation (including pre-award/bid defense activities) and/or maintenance for assigned projects, in line with the agreed RSU site activation strategy and project timelines.
    • Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, resolving issues as required.
    • Ensure collaboration between Regulatory & Site Activation teams, ensuring communication with regions and countries to deliver project scope in compliance with the RSU Management Plan.
    • Review technical and administrative documentation to support business development and initiate study maintenance activities.
    • Provide specialist regulatory and technical scientific support to facilitate efficient business development and ensure compliance with regulatory requirements.
    • Offer guidance and oversight of multi-regional and multi-protocol programs during the initial start-up and maintenance phases.
    • Determine regulatory strategy for submissions and all necessary authorizations, identifying regulatory challenges and offering practical solutions to support the bid process and site activation.
    • Review the regulatory landscape and contribute to accurate regulatory intelligence to support studies.
    • Manage clinical study approvals, authorizations, and the review/negotiation of contracts and essential documents.
    • Collaborate with Quality Management to ensure compliance with quality standards throughout the activation or maintenance phases.
    • Mentor and coach colleagues as needed, ensuring accurate completion and maintenance of internal systems, databases, tracking tools, and project plans.
    • Lead relationships with preferred IQVIA customers and deliver presentations/training to clients, colleagues, and professional bodies.
    • Contribute to monthly study budget planning and reviews.

    Qualifications

    • Bachelor’s Degree in a related field.
    • Minimum of 3 years of clinical research experience, including 1 year in a leadership capacity. Equivalent combination of education, training, and experience will be considered.
    • In-depth knowledge of clinical systems, procedures, and corporate standards.
    • Strong knowledge of medical terminology, regulations, and clinical research processes.
    • Proficiency in Microsoft Office and email applications.
    • Excellent communication, organizational, and interpersonal skills.
    • Strong leadership and effective presentation abilities.
    • Ability to work independently and prioritize tasks effectively.
    • Strong attention to detail with the ability to manage multiple projects simultaneously.
    • Ability to delegate tasks and establish effective working relationships with colleagues and clients.

    About IQVIA

    IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, committed to accelerating the development and commercialization of innovative medical treatments to improve patient outcomes worldwide.

    Learn more at IQVIA Careers.

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    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |