Role Description
Acts as a Clinical Data Reviewer responsible for ensuring high-quality, accurate clinical data through ongoing review, query management, and issue resolution. Monitors patient data (e.g., eligibility, treatments, safety, labs), raises and follows up on queries, and escalates concerns when needed. Supports data quality, compliance, and audit readiness while collaborating with cross-functional teams (Clinical Scientists, Medical Directors, Data Management, and Operations). Provides insights on site performance, identifies data issues, and contributes to training, process improvements, and study deliverables, including interim analyses and final database lock preparations.
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Serves as a Clinical Data Reviewer and identifies any errors in data by performing data review per DRP and issuing/closing queries.
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Performs ongoing review of clinical/medical aspects of the study participant data and documents.
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Examples include but are not limited to:
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Patient eligibility
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Diagnosis
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Medical history and prior treatments
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Study drug administration
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AE/SAE/AESI
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Con meds
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IP dose titration and/or compliance
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Safety labs
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Efficacy assessments (only if specified)
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EOT, EOS, survival, coding, etc.
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Issues clinical data queries and ensures timely follow-up following site responses.
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Communicates to Sponsor any data training needs or concerns for CRAs, sites, etc.
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Provides clinical data review project management status and is viewed as an expert in data clinical/medical review and cleaning.
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Ensures data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
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May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
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Monitors site data entry performance and provides sponsor study team information to assist in identifying root causes of data issues and implementing remedial actions.
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Ensures timely follow-up and resolution of clinical data related compliance issues.
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Continuously assesses opportunities to improve efficiency of tasks and quality of data deliverables.
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May contribute to EDC completion training.
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May exceptionally participate in clinical data review meetings and/or prepare slides for meetings.
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May be involved in preparing or reviewing material for and in exceptional cases may present in data dissemination meetings.
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Will collaborate closely with several Syneos/client functions mainly Clinical Scientists, Study Medical Directors, Data Management, and Clinical Operations.
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May be involved in QC review of patient narratives.
Qualifications
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Equivalent experience, skills, and/or education will also be considered.
Requirements
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Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
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The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
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Further, nothing contained herein should be construed to create an employment contract.
Benefits
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We are passionate about developing our people, through career development and progression.
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We are committed to building an inclusive culture - where you can authentically be yourself.
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We are continuously building the company we all want to work for and our customers want to work with.