As a 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