Clinical Operations Lead

Incyte Corporation; United States; À distance; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

ICH-GCP knowledge

Multitasking

Multinational trials

Regulatory understanding

Communication skills

Formation

BS/BA in science or related field

Description du poste

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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Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

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