As a Clinical Trial Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Preparation of a medical data review plan
This postion is focused on operational support - protocol development, eCRF Setup, Medical review, UAT, Safety reporting, TLF review and CSR at end of trial
- 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 best ways to 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
- Support data processing and ad-hoc TLF creation that is needed to achieve specific cumulative data review needs
- 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 Specific patients with Grade 3 and Grade 4 laboratory abnormalities within Lab shift
table
o Important medical protocol deviations
o Study Status Summary Table
o AE Summary
o SAE Summary
- Develop, write, and program macros or simple programs that process safety data to
support the automation and creation of SSD content
- Execute macros and automated programs to generate 1st version drafts of SSD.
- Review such drafts with strong focus on data integrity and highlight discrepancies that
are likely due to issues originating on the data side
- Communicate to explain data integrity issues and other data-related issues that are currently impacting overall safety and efficacy data profile of the study.
-Support the creation of additional content and explanatory language to be added to SSD to document relevant issues and mitigation strategies that will be implemented.
- Review patient-specific and overall safety data presented in the clinical study report (CSR)
- Prepare the medical protocol deviations for cross functional review
- 3+ years in in a clinical Scientist or similar role would be ideal
- MD degree is a preference
- Oncology experience required
- Experience with Rave/Medidata
- Good understanding data structure, Excel and spreadsheets
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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.
