Responsabilités
The CRA/CRC is responsible for the monitoring or auditing of all activities subject to the, « Bonnes pratiques cliniques ICH: Ligne directrice consolidée, » (GCP), supporting client programs administrated by Watermark ensure project data and summary statements are of known and documented quality.
Exigences
Will be expected to travel extensively to study sites in the US to monitor our clinical and outcome studies.
Successful applicant must have previous experience monitoring clinical trials.
Connaissance de base des exigences réglementaires mondiales et/ou des pratiques de développement pharmaceutique.
Connaissance/compréhension de l'approche et des perspectives des agences de réglementation.
Compétences et capacités essentielles
Bonnes compétences en communication écrite et orale, demonstrated ability to function effectively with all levels of management
Solides compétences en négociation et en établissement de relations
Good understanding of medical / corporate governance principles
Detailed oriented and organized
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