Clinical Expert
BioArctic AB · Stockholms län, Sverige
Role summary The Clinical Expert/Clinical Study Physician will provide medical leadership and oversight for clinical trials in patients primarily with a cent...
Job description
Role summary The Clinical Expert/Clinical Study Physician will provide medical leadership and oversight for clinical trials in patients primarily with a central nervous system (CNS) disorder. The role is responsible for strategic and operational medical aspects of assigned clinical development projects, study designs, sponsor safety surveillance and adjudication of clinical events, communication with investigators, health authorities, ethics committees, and potential other committees relating to study conduct. The role is also required to support regulatory safety reporting as applicable. The physician will work closely with Clinical Operations, Biostatistics, Biomarkers/Imaging experts in the Research Organization and Regulatory team members to ensure high-quality, GCP-compliant study design and conduct and the timely delivery of medically informed decisions. Close co-operation with the medical monitor and other relevant members of the CRO team deployed to conduct the study will be a further critical aspect of the daily work. The role will also provide updates on study progress and report data to relevant project and leadership teams in the company and as applicable present data a...