Clinical Project Manager
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The Clinical Project Manager is responsible for protocol development and conduct including clinical trial planning, budget development and management, timelines, resource management, site management, monitoring, study management, vendor management, and project operational support. The main purpose of the job is to coordinate and manage the activities of individual studies and staff in a manner that ensures all timeframes and targets are met, and that costs are kept in line with the budget. This is a hands-on, full-time position requiring a high level of energy and dedication.
Applies professional knowledge and skills to assist in implementation of clinical trials in accordance with SOPs, Good Clinical Practice, and applicable regulations governing clinical research, with particular emphasis on clinical trial management.
Ensures consistency in written and verbal instructions to investigators and their personnel for compliance with protocol and regulatory requirements.
Primary functions include, but are not limited to, clinical project planning and timeline management, protocol and Case Report Form development, coordination of clinical and non-drug supplies, site communications, assurance of essential documentation, clinical data review, and query resolution.
Leads the process of identifying, evaluating, and qualifying clinical investigators.
Participates in the development and review of study procedures, clarification memos, departmental guidelines and SOPs, and monitoring plans.
Coordinates Clinical Trial Agreements, and payment invoices with internal grants administrators.
Tracks financial information pertaining to study budget.
Manages outside contractors (central laboratories, medical photography companies etc.).
Contributes to study reports.
May conduct pre-study, study initiation and training, interim monitoring, and close-out site visits, as project needs dictate.
CPI Global CRO is a worldwide Contract Research Organization. We provide full service clinical trial management services to a variety of Pharmaceutical and Bio-technology companies. For more information about us please visit our website at www.cpiglobalcro.com.