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
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