As a Medical/Clinical Data Reviewer you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Serve as a Clinical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study sites
Perform ongoing review of clinical/medical aspects of assigned patient data and documents
Communicates any data training needs for CRAs, sites, etc
Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
Provide clinical data Project Management and viewed as an expert in data clinical/medical review and cleaning.
Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation
May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
May be closely involved in data review and identification of readiness for clinical narratives for CSRs
May participate in clinical data review meetings such as:
o Protocol Deviation review
o Data Review and Quality Team (DRQT)
o Statistical Review of Clinical Data (SRCD)
o Safety Monitoring Team (SMT) review
o Slide preparation of top-line results
You are:
Educational scientific background such as MD, PharmD, PhD, Nursing degree, MS
= 5 years of pharmaceutical clinical/medical data review experience is required, including clinical crosscheck experience. 8+ years is preferrable
Experience with Solid Tumor Oncology
Excellent verbal and writing communication in English, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
Experience in coding review
Query writing training
Strong clinical database navigation skills
Strong MS excel, project management
Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process
Must work East coast hours
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:
At ICON, inclusion & belonging are fundamental to our culture and values. 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, 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 through the form below.
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.
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