As a Clinical Scientist you will be joining the worlds largest most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Preparation of a medical data review plan o Determine data retrieval strategies that are required per MRP/protocol Development of a study-specific Table of Contents (TOC) if needed, including core TFLs and compound-specific TFLs o Provide support and suggestions on how to best process data available in the clinical database to serve compound/study needs Review Safety TFLs at a frequency as specified in the data review plan Develops a Safety Slide Deck (SSD) for cross functional review with specific attention to: o Adverse Events (TEAE, Related TEAE) o Treatment Emergent Serious Adverse Events (TESAE) o Adverse Events of Special Interest (AESI) o Worst Post Baseline Laboratory Shift Tables o laboratory abnormalities o Important medical protocol deviations o Study Status Summary Table o AE Summary o SAE Summary Query identifiable safety related medical discrepancies or requests for clarification in the appropriate ED C Prepare a summary of the safety data review that will include: o Data reviewed o Data safety findings observed o A summary of data cleaning requests / observations o Any input from stakeholder review Additional Data Review or Compilation Review patient-specific and overall safety data presented in the clinical study report (CSR) Prepare the medical protocol deviations for cross functional review You are: - Experienced in medical data review - Previous experience in clinical trials and clinical trial set up - Data management experience in life science /pharma - Experience in one of the following TA: cardiovascular/renal, ophthalmology, cell and gene therapy and oncology Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains. Please use the below Lifelancer link for job application and quicker response. https://lifelancer.com/jobs/view/ecfb0dccf734996098b346df18235850