Remote Clinical Trial Operations Lead

Incyte; Wilmington (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

Incyte, a global biopharmaceutical company headquartered in Wilmington, Delaware, seeks a Clinical Operations Lead to support trial execution, liaison with CROs, and manage operational tasks. The role emphasizes effective communication and adherence to study timelines in a fully remote setting.

You will help develop trial documents, manage timelines, monitor site activities, and collaborate with pharmacovigilance and safety teams, contributing to the efficiency and quality of development

Qualifications

• BS/BA degree with strong science emphasis.
• Minimum of three years in biopharmaceutical industry or clinical research.
• Working knowledge of ICH GCP and regulatory requirements.
• Ability to manage multiple priorities across several protocols and therapeutic areas.
• Prior experience in multinational clinical trials is preferred.

Responsibilities

• Assist in review, development and writing of clinical trial documents and manuals.
• Create Master ICF template and update for amendments.
• Participate in site feasibility/evaluation with Clinical Trial Logistics.
• Coordinate and monitor activities at investigational sites; review monitoring trip reports.
• Assist in development of study timelines, recruitment tools, and patient retention plans.
• Plan and organize investigator/coordinator meetings and safety calls.
• Assist in IP and co-medication strategy development.
• Participate in data review and discrepancy resolution.
• Coordinate with Pharmacovigilance and safety groups.
• Monitor study timelines and manage external vendors.
• Participate as a member of the trial team.
• Develop relationships with investigational sites to enhance conduct.
• Act as liaison for study sites to convey information and escalate as needed.
• Participate in special projects to improve Development Operations.

Education

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

Job description

Incyte, a global biopharmaceutical company headquartered in Wilmington, Delaware, seeks a Clinical Operations Lead to support trial execution, liaison with CROs, and manage operational tasks. The role emphasizes effective communication and adherence to study timelines in a fully remote setting.

You will help develop trial documents, manage timelines, monitor site activities, and collaborate with pharmacovigilance and safety teams, contributing to the efficiency and quality of development