Clinical Data Reviewer

hace 3 semanas

Colombia Huila ICON A tiempo completo

As a Clinical Date 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:

- 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
- 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.

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.

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