17814-Reg & Start-Up Lead
IQVIA
Buenos Aires, AR
hace 1 día
source : DirectEmployers Association

Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.Essential Functions

  • Oversee the execution of Site Activation (including pre-award / bid defense activities) and / or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
  • Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.

    Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.

    Create and / or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.

    Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.

    Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.

    Determine regulatory strategy / expectations and parameters for submissions and all necessary authorizations

  • identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
  • Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.

    Execute operational strategy / expectations for maintenance of clinical study approvals, authorizations and review / negotiation of contracts and essential documents.

    Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).

    Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.

    May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations / training to clients, colleagues and professional bodies, as required.

    May be involved in activities related to monthly study budget planning and reviews. Qualifications

  • Bachelor's Degree Related field
  • 3 years clinical research experience, including 1 year experience in a leadership capacity.-Equivalent combination of education, training and experience.
  • In-depth knowledge of clinical systems, procedures, and corporate standards
  • Strong knowledge of medical terminology and regulations
  • Broad knowledge of clinical research
  • Strong knowledge of Microsoft Office and e-mail applications
  • Effective communication, organizational, and interpersonal skills
  • Effective presentation skills
  • Effective leadership skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to delegate
  • Ability to manage multiple projects
  • Attention to detail
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
  • The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

    Learn more at All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday recruiting IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward.

    Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.

    Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled

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