Overview
Medical Scientist responsible for clinical data review, query management, and ensuring data quality for study participant data.
What you'll do
- Review clinical/medical study participant data and identify errors per DRP, issuing or closing queries.
- Perform ongoing review and documentation for items like eligibility, diagnosis, medical history, prior treatments, and study drug administration.
- Issue clinical data queries and ensure timely follow-up after site responses, updating EDC as applicable.
- Communicate data training needs or concerns to Sponsor/CRAs/sites.
- Provide clinical data review project management status as an expert in data clinical/medical review and cleaning.
- Ensure data quality with focus on audit readiness and compliance follow-up and resolution.
What you'll need
- Experience serving as a clinical data reviewer and identifying data errors by performing data review per DRP.
- Ability to escalate clinical/medical aspects of study participant data to the appropriate clinical leaders.
- Ability to manage query closure/re-querying and to update EDC where applicable.
- Knowledge to review clinical data aspects including topics such as AE/SAE/AESI, con meds, and safety labs.
- Ability to collaborate with Clinical Scientists, Study Medical Directors, Data Management, and Clinical Operations.
- Ability to assist in review and contribute guidance for data capture requirements per protocol and reporting requirements.
Details
- Location: IND-Remote.
- Work is remote (as indicated by the ATS location line).
Read the full description and apply on the company’s own careers page.
