Clinical Research Medical AdviserВакансия в архиве

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Уровень зарплаты
Город
Требуемый опыт работы
з/п не указана
Москва, Сокол
3–6 лет

Major Accountabilities:

  • Provide medical expertise for clinical trials
  • Cooperate with CPO colleagues to plan, initiate and implement clinical studies within the therapeutic area context and local specifics
  • Provide consolidated feasibility and site selection input to CPO and global teams
  • Provide protocol & disease training at Investigators Meetings or scientific venues
  • Review and resolution of local medical issues / questions and if necessary, support ICRO to resolve medical and operational issues that arise during the entire course of the study
  • Perform local adverse events review and provide general medical support for safety issues if needed:
    • Provide medical expertise to pharmacovigilance activities in assigned projects
    • Be aware of clinical trial serious adverse events on a country level
  • Provide scientific information or clarifications to the investigators if needed.
  • Provide medical expertise to Clinical Operations activities for safety amendments, INs, etc.
  • Review country or site specific Informed Consent Forms and protocol from medical prospective
  • Ensure accuracy of translation of medical information related to clinical trials, including the patient narrative where appropriate.
  • Participation in early product planning process to ensure that clinical trials conducted is aligned with cross-functional CPO strategy.
  • Support ICRO/ and Global teams in interaction with regional/local regulatory agencies.
  • Support planning, implementation and follow-up of regulatory agency inspections and internal audits.

Requirements:

  • Higher Medical education; Scientific degree (PhD in Medicine)
  • At least 3 years of medical practice (Cardiology is preferable)
  • Russian fluent; English upper intermediate
  • GCP certificate is preferable
  • 1-2 Years in Clinical Operations is preferable
  • Ability to manage a study from the medical perspective, and a demonstrated capability to problem solve and mediate complex medical / operational issues within the regional and therapeutic area context.

Conditions:

  • Permanent role
  • Competitve base salary and other allowance
  • Annual bonus
  • Location: Moscow, Sokol metro

Адрес

Москва, Ленинградский проспект, 72к3, м. Сокол
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Вакансия в архиве