As a Senior 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 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. Thats why weve 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 familys 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 familys 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
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/09c8a05f1ddc87c14c17b5a179ee9a57
