Senior Clinical Trial Manager

Incyte Corporation; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Incyte Corporation, a global biopharmaceutical leader, seeks a Sr Clinical Trial Manager to drive execution of multinational trials. You will oversee timelines, budgets, feasibility, site selection, and vendor oversight, coordinating cross-functional teams to ensure compliant, timely delivery.

Responsibilities include protocol and regulatory document review, risk mitigation, data review, and recruitment planning, with meetings across study teams and stakeholders to optimize study conduct.

Qualifications

• BS/BA degree or equivalent with strong emphasis on science.
• Experience in biopharma or clinical research with multinational trials.
• Ability to manage complex/large trials.
• Working knowledge of ICH GCP and regulatory experience.
• Ability to manage multiple priorities across several protocols.
• Demonstrate leadership and problem solving skills.
• Experience in executing a wide range of clinical trial activities.
• Used to work in a multidisciplinary setting, strong collaborative team player.
• Good planning, prioritization, problem solving and organizational skills.
• Strong communication skills with stakeholders.

Responsibilities

• Deliver Trial(s) on time, within budget, and with high quality.
• Assist in review and writing of clinical trial documents (Protocol, CRFs, ICF, study report).
• Manage evaluation and selection of investigative sites; feasibility.
• Select, coordinate and monitor activities of vendors.
• Review monitoring reports and conduct co-monitoring visits as needed.
• Develop and manage trial timelines, budget and priorities.
• Participate in data review and discrepancy resolution.
• Ensure systems are in place to plan and implement trials and track progress.
• Generate reports to update management on trial progress.
• Ensure appropriate trial supply plans are implemented and managed.
• Develop recruitment and risk-mitigation plans; monitor contingencies.
• Participate in monitoring study safety.
• Develop study quality metrics and act with study team.
• Review CRO/vendor training on protocols and practices.
• Lead multi-disciplinary trial teams; manage study team meetings.
• Act as primary contact for trial between Drug Development and departments.
• Participate in working groups and special projects to improve operations.
• Ensure adherence to Good Clinical Practice and regulations.

Skills

Leadership

Budgeting

Trial management

Cross-functional teamwork

Education

BS/BA in science

Job description

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary (Primary Function)

The Sr Clinical Trial Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, functions as the primary liaison for internal stakeholders and vendors leads multidisciplinary departments initiatives, and provides support for process changes to increase efficiency in study executions.

Essential Functions of the Job (Key responsibilities)

• Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
• Assist 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, Clinical Study Report and other regulatory documents.
• Manage the evaluation and selection of investigative sites; responsible for feasibility.
• Select, coordinate and monitor activities of vendors.
• Review of monitoring reports and conduct co-monitoring visits, as needed.
• Develop and manage trial(s) timelines, budget and priorities.
• Participate in data review and discrepancy resolution.
• Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
• Generate reports to update management on progress of the clinical trial.
• 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.
• Develop 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 vendor training on protocols and practices.
• Lead multi-disciplinary trial teams; include the study team meetings.
• Function as the primary contact for trial(s) between Drug Development and other departments.
• Participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BS/BA degree or a relevant degree with strong emphasis on science or equivalent experience.
• Experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials with a focus on skills and competencies rather than specific years of experience.
• Able to manage complex and/or large 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.
• Demonstrate 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 collaborative 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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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