As a Senior Clinical Scientist, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.
What you will be doing: Preparation of a medical data review plan 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 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 Develop a Safety Slide Deck (SSD) for cross-functional review with specific attention to: Adverse Events (TEAE, Related TEAE) Treatment Emergent Serious Adverse Events (TESAE) Adverse Events of Special Interest (AESI) Worst Post Baseline Laboratory Shift Tables Laboratory abnormalities Important medical protocol deviations Study Status Summary Table AE Summary SAE Summary Query identifiable safety-related medical discrepancies or requests for clarification in the appropriate ED Prepare a summary of the safety data review that will include: Data reviewed Data safety findings observed A summary of data cleaning requests/observations 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 setup Data management experience in life science/pharma Experience in one of the following TA: cardiovascular/renal, ophthalmology, cell and gene therapy, and oncology What ICON can offer you: Our success depends on the quality of our people.
That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits.
Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.
Examples of our benefits include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.Iconplc.Com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
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