Clinical Data Reviewer

Insight Global; Bothell (WA); On-site; USD 120,000 - 150,000; Full time

Job summary

Insight Global in Bothell, WA seeks a seasoned Clinical Reviewer to perform data reviews ahead of major milestones, including interim analyses and submissions. You will conduct point-to-point checks, interpret data, and write queries, acting as an extension of clinicians and study teams across multiple trials.

Requirements include 7+ years of pharma clinical research, hands-on data review, and strong Excel/Data handling skills.

Qualifications

• 7+ years of pharmaceutical clinical research experience.
• Direct, hands-on clinical data review experience.
• Direct experience personally writing and resolving clinical data queries.
• Oncology clinical research experience preferred; strong experience with complex dosing regimens or clinical endpoints acceptable.
• Sufficient clinical knowledge to assess data validity across CRFs.
• Ability to review large-scale Microsoft Excel listings.
• Basic knowledge of CRF design and electronic edit checks.

Responsibilities

• Ensure data readiness for interim and final analyses, submissions, and reviews.
• Review participant-level data according to guidelines and data review plans.
• Conduct point-to-point data checks and interpretive clinical analysis.
• Identify inconsistent, missing, implausible, or clinically significant data.
• Write queries on discrepant data and follow through to resolution.
• Escalate unresolved issues and potential safety signals.
• Collaborate with data management, clinical operations, site management, and study teams.
• Follow SOPs, regulations, and training requirements.
• Attend clinical and study meetings as needed.

Skills

Clinical data review

Data queries writing

Interim/Final analysis

oncology experience

CRF data interpretation

Excel data listings

Data interaction across fields

Documentation and SOPs

Communication skills

Education

Bachelor’s degree or nursing degree

Tools

EDC systems

Job description

Job Description

The Clinical Reviewer performs clinical review ahead of significant project milestones, including interim analysis, study closeout, and submissions. The role includes point-to-point data checks and interpretive analysis, such as reviewing participant-level data, identifying inconsistencies, highlighting errors, and writing queries. The Clinical Reviewer will work as an extension of the clinician or clinical scientist and may support multiple studies.

Skills and Requirements

7+ years of pharmaceutical clinical research experienceDirect, hands-on clinical data review experienceDirect experience personally writing and resolving clinical data queriesOncology clinical research experience preferred; however, candidates with strong experience supporting complex dosing regimens and/or complex clinical endpoints will also be consideredSufficient clinical knowledge to assess whether participant data is scientifically and clinically validUnderstanding of how data across different fields and CRFs interactsProficiency reviewing large-scale Microsoft Excel listingsBasic knowledge of CRF design, electronic edit checks, data-handling conventions, and data-status reportsStrong written and verbal communication skillsAbility to work independently and adjust priorities quicklyStrong attention to detail and clinical judgmentPlusses:Bachelor’s degree or nursing degreePrevious CRA, nursing, or other direct clinical experienceStrong clinical monitoring experiencePrior EDC experienceExperience supporting large Phase 3 clinical trials

Key Responsibilities

• Ensure data readiness for interim and final analyses, submissions, Data Monitoring Committee reviews, and publications
• Review participant-level data according to CRF Completion Guidelines and Data Review Plans
• Conduct point-to-point data checks and interpretive clinical analysis
• Identify inconsistent, missing, implausible, or clinically significant data
• Write queries on discrepant data and follow them through resolution
• Escalate unresolved issues, potential safety signals, and protocol deviations
• Collaborate with data management, clinical operations, site management, and study teams
• Follow applicable SOPs, regulations, and training requirements
• Attend clinical and study meetings as needed

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].