Clinical Research Manager
Merck KGaA
Estado de México , Estado de México, Mexico
hace 5 días

Your role

  • Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
  • Accountable for the oversight of IST / ISS granted by the company, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
  • Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
  • Develop and monitor study budget and timelines
  • Monitor work to ensure quality
  • Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
  • Contribute to the planning and set-up of a study and provide planning parameters, support early access programs on the country level
  • Who you are :

    Minimum qualifications :

  • Bachelor’s degree with 3 plus years of experience, or master’s degree in a medical, life sciences or related field required
  • Fluent in English and Spanish required
  • Preferred qualifications :

  • Three plus years in clinical research in CRO, Pharmaceutical, or Biotechnology industry with most of expertise in trial management preferred
  • Understanding of local / country requirements for clinical trials
  • Managing and steering CROs
  • Networking skills to represent the company with key local stakeholders
  • Proactive issue monitoring and management
  • Manages the budget for all local clinical studies and Global Phase IV studies assigned, as well as the IST / ISS grants.
  • Coordinate within own country study management for all local clinical trials across all phases and therapy areas and for Global Phase IV trials, as well as the IST / ISS grants
  • Support local organization in delivering local medical strategy across the portfolio within own country
  • Work with the CRO in country to ensure local trials are delivered within designed quality, timelines and cost
  • Inscribirse
    Añadir a los favoritos
    Eliminar de mis favoritos
    Mi Correo Electrónico
    Al hacer clic en la opción "Continuar", doy mi consentimiento para que neuvoo procese mis datos de conformidad con lo establecido en su Política de privacidad . Puedo darme de baja o retirar mi autorización en cualquier momento.
    Formulario de postulación