Clinical Data Reviewer

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 experience Direct, hands-on clinical data review experience Direct experience personally writing and resolving clinical data queries Oncology clinical research experience preferred; however, candidates with strong experience supporting complex dosing regimens and/or complex clinical endpoints will also be considered Sufficient clinical knowledge to assess whether participant data is scientifically and clinically valid Understanding of how data across different fields and CRFs interacts Proficiency reviewing large-scale Microsoft Excel listings Basic knowledge of CRF design, electronic edit checks, data-handling conventions, and data-status reports Strong written and verbal communication skills Ability to work independently and adjust priorities quickly Strong attention to detail and clinical judgment Plusses: Bachelor’s degree or nursing degree Previous CRA, nursing, or other direct clinical experience Strong clinical monitoring experience Prior EDC experience Experience 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 [email protected].