Senior Clinical Trial Manager

Incyte Corporation; Wilmington (DE); On-site; USD 120,000 - 160,000; Full time

Job summary

Incyte Corporation, a global biopharmaceutical company headquartered in Wilmington, Delaware, seeks a Sr Clinical Trial Manager to guide trial execution, manage timelines and budgets, and serve as the primary liaison for internal stakeholders and vendors across multiple studies.

You will lead multidisciplinary teams, ensure GCP compliance, oversee site feasibility and vendor activities, support recruitment plans, data reviews, and progress reporting to drive high-quality trial delivery.

Qualifications

• Experience in biopharmaceutical or clinical research with multinational trials.
• Able to manage complex trials and coordinate cross-functional teams.
• Working knowledge of ICH GCP and regulatory requirements.
• Ability to prioritize across multiple protocols and therapeutic areas.
• Demonstrate leadership and problem-solving skills.
• Experience executing trials from initiation to study report.
• Strong communication with diverse stakeholders.
• Excellent planning, prioritization and organizational skills.

Responsibilities

• Deliver trials on time, within budget, and with high quality.
• Review, develop, and write trial documents including protocols, CRFs, and ICFs.
• Manage site feasibility and investigator site selection.
• Coordinate and monitor vendor activities.
• Review monitoring reports and conduct co-monitoring visits.
• Develop and manage trial timelines, budgets, and priorities.
• Participate in data review and discrepancy resolution.
• Ensure systems are set up to plan and implement trials and track progress.
• Generate reports updating management on trial progress.
• Ensure clinical trial supply plans are implemented.
• Develop recruitment and risk-mitigation plans.
• Monitor study safety.
• Develop key study quality metrics and actions with the study team.
• Review CRO/vendor trainings on protocols and practices.
• Lead multidisciplinary trial teams and study meetings.
• Act as primary contact for trials between Drug Development and other departments.
• Contribute to working groups and projects to improve Development Operations.
• Ensure adherence to GCP and applicable regulations.

Skills

Leadership

Problem solving

Communication skills

Project management

GCP knowledge

Team collaboration

Education

BS/BA degree or equivalent 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.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact [e-mail] if you have any questions or concerns or would like to exercise your rights.