Global Clinical Operations Lead

Incyte Corporation; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Incyte Corporation, a global biopharmaceutical company, seeks a Clinical Operations Lead to support trial execution and liaise with CROs and vendors to ensure timely, compliant delivery. The role emphasizes clear communication with the project team and rigorous management of study timelines.

The position involves developing trial documents, managing ICF templates, site evaluations, and coordinating with pharmacovigilance and safety teams to maintain data integrity and quality.

Qualifications

• BS/BA degree or relevant degree with strong emphasis on science.
• Minimum 3 years of experience in 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 template and review/approve site changes with legal and safety input.
• Participate in feasibility/evaluation of investigative sites with Clinical Trial Logistics.
• Coordinate and monitor activities at investigational sites; support US monitoring.
• Assist in development of study timelines, recruitment tools and patient retention plans.
• Plan and organize investigator meetings, DMC/SMC/safety calls and related activities.
• Develop IP and co-medication strategy in collaboration with other departments.
• Participate in data review and resolution of discrepancies.
• Coordinate with pharmacovigilance and safety groups.
• Monitor study timelines and external vendor deliverables.
• Contribute as a trial team member and build site relationships.

Skills

ICH-GCP knowledge

Multitasking

Multinational trials

Regulatory understanding

Communication skills

Education

BS/BA in science or related field

Job description

Incyte Corporation, a global biopharmaceutical company, seeks a Clinical Operations Lead to support trial execution and liaise with CROs and vendors to ensure timely, compliant delivery. The role emphasizes clear communication with the project team and rigorous management of study timelines.

The position involves developing trial documents, managing ICF templates, site evaluations, and coordinating with pharmacovigilance and safety teams to maintain data integrity and quality.