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
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. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
