The Medical Data Scientist performs review of Safety Data by reconciling the information from Safety report with Clinical Database.
Ensures medically relevant information is captured in the Clinical database data entry fields.
Generates Clinical Summaries for the subjects meeting the criteria of serious adverse events, adverse events that led to study discontinuation and clinically significant events determined by the study.
Responsibilities include but not limited to perform review of safety data within Clinical database by generating clinical summaries.
Ensuring queries are posted and actioned within the expected timelines.
Discusses difficult cases and data discrepancies with Senior Manager or above for resolution.
Collaborates with Project Data Manager for timelines and with Data Operations to ensure the tracking /auto-generated template of Subjects meeting the criteria for review is accurate and in time for any milestone.
Collaborate with other study teams across therapeutic areas on safety related matter especially SAE reconciliation.
• Perform review of safety data within Clinical database by reconciling safety report with data information in the clinical database.
• Write Clinical Summaries with quality, accuracy and relevant medical information. Observe the Company writing guidelines and study specific writing guidelines
• Ensuring queries are posted and actioned within the expected timelines
• Participate in the development and implementation of department standards and documents as needed
• Advanced health care degree, Master’s degree in medical science, Nursing, Pharmacy or relevant biological science or healthcare field plus 3 years of experience in job offered.
• Requires 2 years of medical/clinical data review, use of I/J Review, Inform, and other tools collecting clinical data and Word or Excel is a plus
• Requires 2 years of experience supporting Oncology studies and reviewing data in Case Report Forms; managing CRO global team and supporting Oncology studies).
Source: Job Diva – Job Listing