Description We're looking for a Clinical Program Manager, working in Pharmaceuticals and Medical Products industry in 40 Landsdowne Street, Cambridge, Massachusetts, 02139, United States .
Job description:
* Manage Therapeutic Area Programs of a highly complex nature and/or high risk programs including, multiple indications, data safety monitoring boards, endpoint review committees as well as those requiring the coordination of multiple vendors.
* Serve as a strategic GCP quality resource providing GCP technical guidance recommendations to development teams.
* Maximize effectiveness and efficiency in the use of available resources in conducting clinical compound support quality assurance activities.
* Provide GCP QA leadership to drug development teams.
* Act as a quality expert to provide GCP compliance interpretation, consultation, training, and recommendations.
* Coach, educate and collaborate with external sites and cross functional staff in global regulatory readiness activities and responses in support of successful marketing applications.
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