Medical Data Reviewer
hace 1 mes
As a Medical Data Reviewer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will have the opportunity to gain experience working with a large biotech company, a pioneer and industry leader in the area of Antibody research, that utilizes their innovative technology platform across multiple therapeutics areas like Oncology, Infectious Disease, Cardiovascular and Metabolic Diseases.
**What you will be doing**:
- Serve as a Medical 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:
- Protocol Deviation review
- Data Review and Quality Team (DRQT)
- Statistical Review of Clinical Data (SRCD)
- Safety Monitoring Team (SMT) review
- Slide preparation of top-line results
**You are**:
- Educational scientific background such as MD, PharmD, PhD, Nursing degree, MS
- Large pharmaceutical clinical/medical data review experience is required, including clinical crosscheck experience.
- 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.
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