Clinical Data Reviewer
A pharmaceutical company is in search for a dynamic Clinical Data Reviewer to strengthen its biometrics team in France.
- Ensure the medical review of safety and efficacy data collected in ongoing clinical studies, to ensure the medical relevance of data used in statistical analyses and clinical study reports.
- Verify the medical consistency of patients' clinical data: laboratory results, adverse events, medical history, vital signs, efficacy measures and treatments.
- Monitor the resolution of inconsistencies and problems detected.
- Participate in the review of protocols, CRFs, clinical study reports, and other documents related to medical data
- Detection and review of significant adverse events.
- Reconciliation of serious adverse events and events of interest in collaboration with Pharmacovigilance.
- Detection and review of deviations from medical and therapeutic protocol.
- Participate in the implementation of new medical review activities (specifications, validation, tests, writing procedures, etc.).
- Participate in the archiving of documents that are part of the Trial Master File.
- Participate in the training of new Medical Reviewers, Medical Review Trainees and other departments (e.g. CRA).
Skills and Requirements
- Pharmacist or doctor with, if possible, a specialization in clinical trials
- At least 3 years of experience in medical data review or Pharmacovigilance or as an CRA.
- Knowledge of databases and coding dictionaries (MedDRA, WHO-DD) is a plus
- Knowledge of SAS programming is a plus
- Rigorous, responsive and adaptable, with a spirit of synthesis and scientific and medical curiosity.
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