Global Clinical Trials Operations Lead

Incyte Corporation; Wilmington (DE); On-site; USD 110,000 - 170,000; Full time

Job summary

The Clinical Operations Lead at Incyte Corporation supports the Clinical Trial Manager/operational team in execution of the trial(s). The role includes direct liaison with CROs and other vendors to manage trial operational tasks and maintain communication to ensure alignment with study timelines.

Key duties include developing and reviewing trial documents, coordinating site monitoring, planning timelines, recruitment tools, and vendor oversight with Pharmacovigilance and safety groups to ensure

Qualifications

• BS/BA degree or a relevant degree with strong emphasis on science.
• Minimum of three years of experience in the biopharmaceutical industry or other relevant clinical research experience.
• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Prior experience in multinational clinical trials is preferred.

Responsibilities

• Assist in the review, development and writing of clinical trial documents and manuals, including study manuals, laboratory or biomarker plans, and other supporting documents.
• Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.
• Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Logistics group.
• Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.
• Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.
• Plan and organized meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.).
• Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.
• Participate in data review and discrepancy resolution.
• Participate in coordinating efforts with internal Pharmacovigilance, and safety group.
• Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc).
• Participate as a member of the multi-disciplinary trial(s) team.
• Develop relationships with investigational sites and institutions to enhance conduct of the trial.
• Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.
• Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.

Skills

ICH GCP knowledge

Regulatory/health authority experience

Multitasking across protocols

CRO coordination

Education

BS/BA degree or relevant science-focused degree

Job description

The Clinical Operations Lead at Incyte Corporation supports the Clinical Trial Manager/operational team in execution of the trial(s). The role includes direct liaison with CROs and other vendors to manage trial operational tasks and maintain communication to ensure alignment with study timelines.

Key duties include developing and reviewing trial documents, coordinating site monitoring, planning timelines, recruitment tools, and vendor oversight with Pharmacovigilance and safety groups to ensure