Clinical Data Reviewer

Highly Competitive
  1. Permanent
  2. Clinical Outsourcing
  3. France
Paris, France
Posting date: 08 Feb 2021
35523

A pharmaceutical company is in search for a dynamic Clinical Data Reviewer to strengthen its biometrics team in France.

Job Responsibilities

  • 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.

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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