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.
Please visit our website at www.epmscientific.com