Clinical Data Reviewer - Oncology

Job Responsibilities

• Ensure data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications
• Conduct point-to-point data checks (e.g., verifying the presence of a lab test that satisfies study inclusion criteria) and interpretive analysis (e.g., reviewing to identify inconsistencies in the participant’s data)
• Generate queries on discrepant data and follow to resolution including escalation of issues that cannot be resolved through the query process
• Create and use data review best practices and associated data review tools to identify trends and any safety signals
• Identify protocol deviations during routine clinical review and escalate as appropriate

Qualifications

• Bachelor’s degree or nursing degree is preferred
• At least 7 years of clinical research experience in the pharmaceutical industry (strong monitoring experience is a plus)
• Prior EDC experience preferred
• Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date))
• Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis
• Ability to work independently in a virtual setting and as part of a remote team
• Prioritize and adjust work priorities quickly as needed to meet deadlines (i.e., fluid, flexible work style)
• Possess basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions, and interpretation of data status reports
• Good written and oral communication skills with strong attention to detail required

Benefits

• Company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time

Pay

Salary Range: $80,600.00 - $145,000.00

Schedule

Not specified