Clinical Operations Lead

Incyte; United States; In loco; USD 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Formazione

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

Descrizione del lavoro

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary (Primary Function)

The Clinical Operations Lead supports the Clinical Trial Manager/operational team in execution of the trial (s). The position includes direct liaison with CROs and other ancillary vendors, as appropriate, to manage relevant trial(s) operational tasks. The Lead maintains effective communication with project team through oral and written correspondence, status reports to ensure alignment with study timelines.

Essential Functions Of The Job (Key Responsibilities)

• Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to 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.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• 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 assisting the conduct and management of multinational clinical trials is preferred.

Disclaimer:

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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