Clinical Data Reviewer, Oncology

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Conduct clinical evaluations prior to key project milestones, such as interim analysis, study closure, and submission.

• Ensure readiness of data for interim and final evaluations, submission snapshots, Data Monitoring Committee assessments, and publications.

• Review participant-level data across studies in accordance with CRF Completion Guidelines and the Data Review Plan.

• Perform point-to-point data verifications and interpretive analyses to detect inconsistencies.

• Generate inquiries on discrepant data and oversee their resolution, escalating any unresolved issues.

• Develop and implement best practices and tools for data review to identify trends and safety signals.

• Recognize and escalate protocol deviations during routine clinical evaluations.

• Adhere to relevant SOPs, regulations, and training requirements while enhancing the quality and efficiency of clinical procedures.

• Collaborate with data management, clinical and site management, and other members of the study team.

• Participate in clinical and study meetings.

⛳️ Requirements

• Experience as a Sr CRA or CTM in Oncology is mandatory.

• Candidates must reside in the US or Canada without the need for sponsorship.

• A bachelor's degree or nursing degree is preferred.

• Minimum of 7 years of clinical research experience in the pharmaceutical industry.

• Strong monitoring experience is advantageous.

• Direct experience in clinical review and query writing/resolution is required.

• Adequate clinical knowledge to evaluate whether participant data is scientifically and clinically valid.

• Previous EDC experience is preferred.

• Proficiency in reviewing large-scale listings in Microsoft Excel, including filtering, sorting, and date formatting.

• Basic understanding of the interaction between data points from various fields/CRFs and how data collection affects analysis.

• Ability to work autonomously in a virtual environment as well as collaboratively within a remote team.

• Capability to prioritize and swiftly adjust work tasks to meet deadlines.

• Fundamental knowledge of data management, including case report form design, electronic edit checks, data handling conventions, and data status reporting.

• Strong written and verbal communication skills with a keen attention to detail.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Company vehicle or car allowance.

• Medical, Dental, and Vision health benefits.

• 401k with company matching.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions/bonuses based on individual and company performance.

• Flexible paid time off (PTO) and sick leave.

• Reasonable accommodations for applicants and employees with disabilities.