As a Senior Clinical Scientist you will be joining the world’s 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 EDC

•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

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.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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 specialised 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, subsidised travel passes, health assessments, among others