Medical Data Reviewer
ICON PLC, Can be based anywhere
Medical Data Reviewer
Salary not available. View on company website.
ICON PLC, Can be based anywhere
- Full time
- Permanent
- Remote working
Posted today, 30 Oct | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
job Ref: c3e05995a5f0468fb340b33687d484e1
Full Job Description
- 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
- 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
Working in ICON Strategic Solutions is more than a job, it's a calling for people who care and have passion for improving patients' lives. It takes courage to move from one job to another and the process involves careful consideration. At ICON, we care about our people as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you., 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., As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond. ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world's leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact. Why choose a career with ICON Strategic Solutions? Meaningful Work: You'll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives. Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally. Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently. Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization. Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.