Posted to MedZilla on 1/22/2020

EPM Scientific

US-MA, Clinical Study Manager 452431264093-MZ


Our client, a Global Pharmaceutical company, has multiple openings for Clinical Study Managers, (Clinical Project Managers, Clinical Trial Managers, Sr. CRA’s, and Line Managers will all be considered).

The Senior Study Manager is responsible for assuring the coordination of the operational aspects and proper conduct of a clinical study, including compliance within the FDA.
 Accountable for study execution, tracking and management of study delivery.
• Manages feasibility and determines global study allocation to appropriate countries and sites, ensuring efficient use of resources and adherence to company policies and strategic initiatives.
• Develops and maintains the global study budget, ensuring cost effectiveness and addressing and escalate issues as appropriate.
• Ensures set up and maintenance of all systems in order to plan and implement the study and track progress.
• Ensures appropriate clinical trial supply strategy is implemented and managed.
• Develops recruitment plan, manages risk, monitors progress and implements contingencies as required.
• Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data.
• Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
• Accountable for timely delivery of scientifically and operationally robust study documents.
• Contributes to the development of the study protocol
• Ensures development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines.
2 Years of Pharmaceutical Industry Experience is preferred.
Relocation Assistance available as well.

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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.