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Clinical Quality&Training Manager
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To provide direction, leadership and management of the local Affiliate Process and Training group, if applicable. To ensure the consistent interpretation and effective implementation of quality standards applying risk management in clinical trials conducted by the affiliate.
*Line Management - Provide line management to the local Affiliate Process and Training
*Strategic direction - Provide affiliate process and training strategic direction in line with the global and regional APT(Affiliate Process& Training) business plans/goals and country business needs and priorities
*Drive consistency of quality standards implementation in the affiliate
*Ensure effective training programs are implemented to affiliate staff (including in-sourced eRO staff, if applicable) in compliance with global and local requirements
*Lead the implementation of affiliate Quality Risk Management
*Five to ten years experience in multiple therapeutic areas, GLP/GMPor in Clinical Quality Assurance of which at least three years should be in a Manager role. Expert knowledge of ICH/GCP, PD SOPs and local regulatory requirements.
*University degree or equivalent in a scientific discipline
*Able to communicate clearly and accurately in both written and spoken English
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