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Clinical Trial Manager

Company: Global Channel Management, Inc.
Location: East Orange
Posted on: December 5, 2019

Job Description:

Clinical Trial Manager needs 3 to 5 years of pharmaceuticals/biotech experience. Clinical Trial Manager requires: 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections. Knowledge and experience in clinical study budgeting including timeline and the application of clinical trial performance metrics. Demonstrated ability to support the development and management of various aspects of the end to end study operational plan Demonstrated ability to support the operational execution and delivery of various aspects of a quality clinical trial. Demonstrated experience in change management initiatives preferred. Program and project management experience preferred International experience a plus. Knowledge of drug development and FDA GCP/ICH regulatory guidelines. Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc. Clinical trial management system (CTMS) background Change Management CTM experience that includes budget/forecast/accrual and vendor oversight. Clinical Trial Manager duties: Responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRIs SOPs and policies Responsible for monitoring assigned aspects of the study operational plan Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation processes with input from key stakeholders. Supports the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness Responsible for supporting the management and maintenance of the study TMF. Supports the Sr. CTM in managing the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team and key stakeholders..

Keywords: Global Channel Management, Inc., New York , Clinical Trial Manager, Healthcare , East Orange, New York

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