Senior Clinical Trials Operations Lead

Incyte; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Incyte, a global biopharmaceutical company, is seeking a Clinical Operations Lead to support trial execution and liaise with CROs and vendors. You will ensure alignment with study timelines through effective written and oral communication.

The role requires coordinating site activities, developing study timelines, and collaborating across departments to optimize trial efficiency and quality. Strong ICH GCP knowledge and multinational trial experience are preferred.

Qualifications

• BS/BA degree or relevant degree with strength in science.
• Minimum of three years of experience in the biopharmaceutical industry or clinical research.
• Working knowledge of ICH Good Clinical Practices and regulatory/health authority experience.
• Ability to manage multiple priorities across several protocols and therapeutic areas.
• Prior experience in multinational clinical trials is preferred.

Responsibilities

• Assist in reviewing, developing and writing clinical trial documents and manuals.
• Create Master ICF templates and review site changes with legal and safety input.
• Participate in feasibility and evaluation of investigative sites with Clinical Trial Logistics.
• Coordinate and monitor activities at investigational sites and support US monitoring.
• Develop and manage study timelines and priorities, including recruitment strategies.
• Plan and organize investigator/coordinator meetings and safety calls.
• Assist in IP and co-medication strategy development with other departments.
• Participate in data review and discrepancy resolution.
• Coordinate with internal Pharmacovigilance and safety groups.
• Monitor study timelines and external vendors (Monitoring, Sample management, IVRS, Lab).
• Represent the trial in multi-disciplinary teams and engage investigational sites.

Education

BS/BA degree or relevant degree with strong emphasis on science

Job description

Incyte, a global biopharmaceutical company, is seeking a Clinical Operations Lead to support trial execution and liaise with CROs and vendors. You will ensure alignment with study timelines through effective written and oral communication.

The role requires coordinating site activities, developing study timelines, and collaborating across departments to optimize trial efficiency and quality. Strong ICH GCP knowledge and multinational trial experience are preferred.