Clinical Trial Manager clinical trial manager clinical trial manager clinical trial manager clinical trial manager

по договоренности
Москва
Опыт работы не важен

Job Responsibilities:

  • Monitoring of organizations conducting clinical trials, participation in the organization and monitoring of clinical trials I - IV phase
  • Participation in the evaluation and selection of potential research centers to participate in the study
  • Participation in the preparation and collection of research documents at the center level
  • Participation in the negotiation of contracts with research centers
  • Ensuring the provision of medical institutions all needed to begin the study of the documents and signing procedures established in terms
  • Coordination of supply of drug (s) and research materials to the centers on time
  • Participation in meetings of researchers and trainings on conducting research in accordance with the task
  • Ensure the proper performance of all the main stages of research in the research center (confirmed agreements with research centers, recruitment of patients, completion of studies in research centers, etc.) in accordance with the established time frame
  • Ensuring the availability of quality data in clinical trials in accordance with the established time frame, research budget
  • Participation in the coordination of work with suppliers and contract research organizations (CRO)
  • Close cooperation with the research team to ensure timely provision of the required amount of the drug and research materials as well as to resolve all issues arising in the course of the study
  • Carrying out all procedures of monitoring visits, including verification of primary documentation (qualification, initiation, regular monitoring, visit of closure of the center) in accordance with the monitoring plan and the necessary contacts with the centers
  • Assistance in the process of resolving data requests (both in the center and with database management)
  • Timely reporting of monitoring visits under the supervision of the project Manager
  • Participation in the management of the clinical trial file in conjunction with the study coordinator
  • Perform other functions related to the monitoring of the blind turnover of the test drug and the verification of the operation of the blind CRS monitors, including co-monitoring and verification of reports
    • Work Environment:

    • Competitive compensation and benefit program
    • Salary rate is under discussion
    • Medical insurance
      • Requirements:

      • Higher medical, biological or pharmaceutical education
      • Experience with the blind monitoring at least 10 clinical trials (Preferable GCP trials)
      • Experience in clinical research
      • English
      • Understanding the drug development process as a whole
      • Knowledge of ICH GCP, Russian and international regulatory requirements, standard procedures of the company
      • Strong computer and Internet skills, including MSOffice products such as Excel, Word, Power Point;
      • Business correspondence skills
      • Organizational skills
      • High motivation and initiative
      • Ability to work effectively in a team on several projects
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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