Senior Clinical Trial Manager

Incyte Corporation•UNAVAILABLE, UNAVAILABLE

10d

About The Position

The Senior Clinical Trial Manager provides input into the operational implementation of clinical trials and manages trial timelines, budgets, feasibility, country identification, site selection, and patient recruitment. The role serves as the primary liaison for internal stakeholders and vendors, leads multidisciplinary initiatives, and supports process changes that improve study execution efficiency. The position is accountable for delivering trials on time, within budget, and at the highest achievable quality. It oversees trial planning and execution from initiation through clinical study report, including vendor and site oversight, trial systems and supplies, recruitment and risk mitigation, data review, safety monitoring, and compliance with Good Clinical Practice and applicable regulations. The Senior Clinical Trial Manager leads multidisciplinary trial teams and communicates trial progress to management.

Requirements

BS/BA degree, a relevant degree with a strong emphasis on science, or equivalent experience.
Experience in the biopharmaceutical industry or other relevant clinical research experience conducting and managing multinational clinical trials.
Ability to manage complex and/or large trials.
Working knowledge of ICH Good Clinical Practices and relevant regulatory or health authority experience.
Ability to manage multiple priorities across several protocols and therapeutic areas simultaneously.
Leadership and problem-solving skills.
Experience executing a wide range of clinical trial activities, from initiation through clinical study report.
Ability to work in a multidisciplinary setting as a collaborative team player and adapt to a changing environment.
Strong planning, prioritization, problem-solving, and organizational skills; customer orientation; and ability to work independently.
Strong communication skills and ability to communicate with a broad range of stakeholders and build positive relationships.

Responsibilities

Deliver clinical trials on time, within budget, and with the highest achievable quality.
Assist with reviewing, developing, and writing clinical trial documents and manuals, including protocols, case report forms, informed consent forms, clinical study reports, and other regulatory documents.
Evaluate and select investigative sites and manage feasibility activities.
Select, coordinate, and monitor vendors.
Review monitoring reports and conduct co-monitoring visits as needed.
Develop and manage trial timelines, budgets, and priorities.
Participate in data review and discrepancy resolution.
Set up and maintain systems used to plan and implement trials and track progress.
Generate reports to update management on clinical trial progress.
Ensure appropriate clinical trial supply plans are implemented and managed.
Develop recruitment and risk-mitigation plans, monitor them, and implement contingencies as required.
Participate in monitoring study safety.
Develop key study quality metrics, such as eligibility and primary endpoint data, and determine appropriate actions with the study team.
Perform initial reviews of CRO and other third-party vendor training on protocols and practices.
Lead multidisciplinary trial teams, including study team meetings.
Serve as the primary trial contact between Drug Development and other departments.
Participate in working groups and perform assigned special projects to improve the efficiency, effectiveness, and quality of the Development Operations Department.
Ensure adherence to Good Clinical Practice and applicable local and international regulations.