Medical Scientist

Job Summary

Medical Scientist

Responsibilities

• Serves as a Clinical Data Reviewer and identify any errors in data by performing data review per DRP and issuing/closing queries.
• Performs ongoing review of clinical/medical aspects of the study participant data and documents (escalates to Syneos/client Clinical Scientist and/or Study Medical Director, as appropriate).
• Examples include but not limited to: Patient eligibility, diagnosis, medical history and prior treatments, study drug administration, AE/SAE/AESI, con meds, IP dose titration and/or compliance, safety labs, efficacy assessments (only if specified), EOT, EOS, survival, coding, etc.
• Issues clinical data queries and ensure timely follow up following site responses as to whether the queries are appropriately addressed, and updates in EDC done, if applicable, by either closing out the queries or re-querying, as applicable and with consultation with the clinical team as needed.
• Communicates to Sponsor any data training needs or concerns for CRAs, sites, etc.
• Provides clinical data review project management status and is viewed as an expert in data clinical/medical review and cleaning.
• Ensures data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
• May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
• Monitors site data entry performance and provide sponsor study team information to assist in identifying root causes of data issues and implementing remedial actions.
• Ensures timely follow-up and resolution of clinical data related compliance issues.
• Continuously assess opportunities to improve efficiency of tasks and quality of data deliverables.
• May contribute to EDC completion training.
• May exceptionally participate in clinical data review meetings and/or prepare slides for meetings.
• May be involved in preparing or review material for and in exceptional cases may present in data dissemination meetings.
• Will collaborate closely with several Syneos client functions mainly Clinical Scientists, Study Medical Directors, Data Management and Clinical Operations to execute clinical data reviews and activities during study conduct, including prior to data cuts for snapshots, interim analysis, DSUR, IBs, regulatory requests, study site close-outs and final DBL.
• May be involved in QC review of patient narratives.

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