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.