Regulatory and Contract Support Associate
Buenos Aires, AR
hace 1 día
source : DirectEmployers Association

Are you interested in expanding your expertise in regulatory and contract area, working in a cross cultural environment? This job opportunity is for you! PURPOSE Provides training, guidance and mentoring to Monitors for assigned countries, for regulatory and contracting activities through start-up and maintenance. RESPONSIBILITIES

  • Periodically reviews with country manager the list of newly hired monitors and / or monitors assigned to new activities ("monitors")
  • Proactively reaches out to "monitors" to provide guidance and directions towards existing regulatory and contracting country materials and resources.
  • Within two weeks of onboarding or as soon as possible after new activity assignment, reaches out to "monitors" to make sure trainings have been taken and properly understood.
  • Organizes retraining as needed.

  • Within one month of onboarding or as soon as possible after new activity assignments, goes through department organization, roles and responsibilities with the internal team for the delivery of respective activities.
  • Showcases company systems use for the delivery of respective activities
  • Upon "monitors" assignments to study / task, reviews together with "monitors" the list of assigned sites and target timelines to support "monitors" in planning their activities
  • Provides ongoing support to "monitors" through the preparation of their first deliverables : first ICF country customization, first submission to Ethics Committee, first submission to Regulatory Authority, first contract negotiation and QC, filing and tracking of first submission / contract / ICF
  • Provides adhoc support as needed for country intelligence
  • Contributes to country material updates (regulatory and ethics country trainings, list of documents to submit, ICF adaptation document and guidance, contract management)
  • Prepares and / or reviews regulatory documentation in area of expertise, as appropriate.
  • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Degree in life science-related discipline or professional equivalent
  • At least 1 year of working experience in Site Management, Regulatory or Contract Management areas REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Good understanding of the Clinical Research environment, laws and related guidelines, as appropriate
  • Strong software and computer skills, including MS Office applications
  • Knowledge of applicable SOPs and company's Corporate Standards
  • Good, solid interpersonal communication (oral and written), organization and negotiating skills
  • Ability to work on several activities, with direction from senior staff as appropriate
  • Availability for occasional travelAt 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 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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