Are are looking for opportunities to develop your career? Join Novo Nordisk Ukraine and get a life-changing career!
Main responsibilitiesPrepare trial documents for submission to IRBs/IECs and Regulatory Authorities.Perform sites feasibility and investigators’ selection.Communicate with sites for ensuring adequate enrolment rate.Perform clinical on-site monitoring activities (source data verification and review, drug accountability, data collection etc.)Prepare and submit Monitoring Visit Reports within defined timelines.Maintain and update study related documentation from CRA's area responsibility.Manage and complete reporting of Serious Adverse Events happened within Clinical Trials on site.Provide study related training for Investigators on the routing practice.Update central data base in Clinical Trial Management System regularly.
QualificationsYou hold University degree (life science or medical/pharmaceutical preferred).You have minimum 1 year of experience in on-site monitoring; however, other relevant experiences and skills may be considered when considering the candidate’s eligibility.Your experience in local study management will be a strong advantage.Strong knowledge of GCP and local laws and regulations for clinical trials.Experience in preparing documents for submission to IRBs/IECs and Regulatory Authorities.Computer literacy (e.g. EDC, IMPACT, MS Office, etc.).Excellent verbal and written communication skills in English.Willing and able to travel (up to 50% of the time).Excellent organizational and time management skills as well as working flexibility.Valid driving licence.
Millions rely on usTo work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.