Global Clinical Trial Operations Lead

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

Job summary

Incyte Corporation is seeking a Clinical Operations Lead to support the Clinical Trial Manager and operational teams in executing trials. You will liaise with CROs and vendors, maintaining communication and status reports to align with study timelines.

You will help develop trial documents, manage site feasibility and monitoring activities, and support timelines, recruitment strategies, and risk management.

Qualifications

• BS/BA degree or a relevant science-focused degree.
• Minimum of three years of experience in biopharmaceutical industry or clinical research.
• Working knowledge of ICH GCP and regulatory health authority experience.
• Ability to manage multiple priorities across several protocols and therapeutic areas.

Responsibilities

• Assist in review, development and writing of clinical trial documents and manuals.
• Create Master ICF template and review site changes with input from legal and safety.
• Participate in feasibility and evaluation of investigative sites with Clinical Trial Logistics.
• Coordinate and monitor activities at investigational sites and review monitoring trip reports.
• Assist in development of study timelines, recruitment tools and patient retention plans.
• Plan and organize investigator/coordinator meetings, DMC/SMC/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 management of external vendors (monitoring, sample management, IVRS, labs).
• Be a member of the multi-disciplinary trial team and develop relationships with sites.

Skills

Clinical trial management

ICH GCP knowledge

Multitasking

Education

BS/BA in science

Job description

Incyte Corporation is seeking a Clinical Operations Lead to support the Clinical Trial Manager and operational teams in executing trials. You will liaise with CROs and vendors, maintaining communication and status reports to align with study timelines.

You will help develop trial documents, manage site feasibility and monitoring activities, and support timelines, recruitment strategies, and risk management.