Clinical Data Reviewer job in Paris, France

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First Name*

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Job type: Permanent

Discipline: Clinical Outsourcing

Location: France

This vacancy has now expired. Please see similar roles below...

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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Salary

Highly Competitive

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