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Clinical Project Manager

New Jersey All, NJ

Posted: 05/29/2019 Job Type: Clinical Job Number: JN -052019-24965

The Clinical Project Manager must have experience in vendor management and oversight including budget forecasting and accruals. Also, needs experience working directly with sites and study coordinators in helping drive screening and enrollment activity.

Responsible for supporting the Senior Clinical Trial Manager/Operational Study Lead, and for managing various aspects of the operational execution and delivery of quality studies, including in process quality control activities (e.g. quality checks and balances to ensure inspection readiness, Enrollment, Metrics, Milestones, Timelines and Budget)

Supports the Sr. CTM/Operational Study Lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)

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

Responsible for monitoring assigned aspects of the study operational plan

Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation

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

Education and Experience:

Bachelor s degree

Minimum of 3 to 5 years of Clinical Trial Management pharmaceuticals/biotech experience with emphasis on Phase II-IV clinical trials

Process and system thinking, customer orientation, and ability to work in multidisciplinary study teams and to execute within a matrix management model

Experience in execution of clinical research trials, including GCP and regulatory guidelines 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

Global experience

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