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PSG Global Solutions

Clinical QC Coordinator/Specialist/Manager

PSG Global Solutions, Cambridge, Massachusetts, us, 02140


Description

We're looking for a

Clinical QC Coordinator/Specialist/Manager , working in

Pharmaceuticals and Medical Products

industry in

87 Cambridge Park Drive, Cambridge, Massachusetts, 02472, United States .

Responsibilities:

Reviews clinical documents (e.g., manuals, study plans, etc.) for compliance with regulations, regulatory guidelines, and SOPs.

Supports enhancement of QC systems, as needed, to support clinical operations, medical writing, and data management.

Writes and reviews Clinical Operation SOPs and provides input during the review of cross-functional SOP review.

Works with QA team, opens and reports process deviations from clinical operation procedures and tracks until completion.

Represents GCP clinical project team meetings and other cross-functional meetings and discussions.

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