- 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.
- 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.
- Permanent role
- Competitve base salary and other allowance
- Annual bonus
- Location: Moscow, Sokol metro
Москва, Ленинградский проспект, 72к3, м. СоколПоказать на карте
Полная занятость, полный день