The clinical data review individual will work as a key member of the data review team. This individual will work independently with guidance in only the most complex situations and serve as a close partner to the physician and clinical scientist on the team.
This position will have key relationships internally with clinical project teams, operations and data management, as well as with other members of the data review team.
Review and interpret medical data and clinical trial data, submit queries to data management and sign off on responses from sites.
Will be responsible for all key components of data review including but not limited to eligibility, adverse events, dosing and study termination.
Ensure own work, and work of team, is compliant with Safety, Health and Environment standards and all other relevant internal and external regulations so that study is audit ready.
Requirements:
Considerable relevant oncology clinical experience in the pharmaceutical industry is required with immune-therapy clinical trials experience preferred.
Good transferable project experience across phases I - III drug development.
Experience managing and interpreting the results of clinical trials
Experience being on a data review team is desirable focusing on good communication, passion for customers and working collaboratively
Sufficient technical and disease area knowledge to be able to interact with confidence with internal and external partners.