Clinical Trial Manager

Overview

Summary

The position is accountable for the management of all aspects of Incyte sponsored clinical trial(s). The responsibilities would include (non-exhaustive) : (1) Provide input to the overall operational trial(s) strategic implementation; (2) Manage full trial(s) execution within agreed timelines and budget, (feasibility, country identification, sites selection, study documents, recruitment, data cleaning…); (3) Manage the study team and vendors; function as the primary liaison for internal stakeholders, as appropriate

Duties and Responsibilities

• Is accountable to deliver Trial(s) on time, within budget, and with highest achievable quality
• Assists in the review, development and / or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, Informed Consent Forms, Study plan, Communication plan, risk Management plan…
• Is responsible for feasibility and lead the evaluation and selection of countries and investigative sites
• Select, coordinate and monitor activities of vendors
• Develop and manage trial(s) timelines and budget;
• Coordinate data cleaning and data review
• Ensure set up and maintenance of all systems in order to plan and track trial(s) progress
• Generate reports to update management on conduct of trial(s)
• Ensure appropriate clinical trial supply plans are implemented and managed
• Develop recruitment plans, risk-mitigation plan, monitor and implement contingencies as required
• Participate in monitoring study safety
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team
• Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
• Assist with CRA and third party vendor training on protocols and practices
• Lead the multi-disciplinary trial(s) team(s)
• Function as the primary contact for trial(s) between Drug Development and other departments;
• Assume responsibility to participate as a member of working groups and perform special projects, as assigned
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

Requirements

Disclaimer : The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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