Clinical Data Reviewer

As a 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

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

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.