Clinical Data Reviewer – Oncology

This is a fully remote position, open to applicants in United States, +3 more states.

📋 Description

• Ensure data readiness for key milestones, including but not limited to interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews, and publications.

• Review participant-level data throughout the study in compliance with CRF Completion Guidelines (CCGs) and the Data Review Plan (DRP).

• Perform point-to-point data checks (e.g., confirming the presence of a lab test that meets study inclusion criteria) and conduct interpretive analysis (e.g., identifying inconsistencies in participant data).

• Generate queries regarding discrepant data and ensure resolution, including escalating issues that cannot be resolved via the query process.

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

• May identify protocol deviations during routine clinical reviews and escalate them as necessary.

• Adhere to relevant SOPs and regulations, demonstrating a thorough understanding of and compliance with applicable training requirements, while continually seeking enhancements in the quality and efficiency of clinical procedures.

• May collaborate with data management, clinical, and site management, as well as other members of the study team.

• Attend Clinical Meetings and Study Meetings as required.

⛳️ Requirements

• A Bachelor’s degree or nursing degree is preferred.

• Minimum of 7 years of clinical research experience within the pharmaceutical industry (strong monitoring experience is advantageous).

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

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

• Prior experience with EDC is preferred.

• Proficient in reviewing large-scale listings in Microsoft Excel (filtering, sorting, and formatting data).

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

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

• Capability to quickly prioritize and adjust work tasks as necessary to meet deadlines (i.e., maintaining a fluid and flexible work style).

• Basic knowledge of data management, including case report form design, the functionality of electronic edit checks, implementation of data handling conventions, and interpretation of data status reports.

• Strong written and oral communication skills with a keen attention to detail are required for meetings, as necessary.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

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