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
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 review
Ensure set up and maintenance of all systems in order to plan and implement trial(s) and track 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
Review of monitoring reports and conduct co-monitoring visits, as needed
Lead the multi-disciplinary trials teams; include the study team meetings
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
BS / BA degree or a relevant degree with strong emphasis on science;
Minimum of three years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory / health authority experience
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
Demonstrated leadership and problem solving skills
Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment
Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently
Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships
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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