Clinical Operations Lead

Incyte Corporation•Remote Location, UNAVAILABLE

About The Position

The Clinical Operations Lead supports the Clinical Trial Manager and operational team in executing clinical trials. The role liaises directly with CROs and other ancillary vendors to manage trial operational tasks, and maintains effective communication with the project team through oral and written correspondence and status reports to ensure alignment with study timelines. The position also contributes to the functioning and improvement of the Development Operations Department.

Requirements

BS/BA degree or a relevant degree with a strong emphasis on science.
At least three years of experience in the biopharmaceutical industry or other relevant clinical research experience.
Working knowledge of ICH Good Clinical Practices and other relevant regulatory or health authority experience.
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

Nice To Haves

Prior experience assisting with the conduct and management of multinational clinical trials is preferred.

Responsibilities

Assist in reviewing, developing, and writing clinical trial documents and manuals, including study manuals, laboratory or biomarker plans, and supporting documents.
Create the Master ICF template; review and approve site changes in consultation with legal and safety teams when warranted; and update the template for new risks and amendment information.
Participate in investigative-site feasibility and evaluation in collaboration with the Clinical Trial Logistics group.
Coordinate and monitor investigational-site activities, review monitoring trip reports, and support the US monitoring organization.
Assist with developing and managing study timelines and priorities, including recruitment tools and strategies and patient-retention plans.
Plan and organize meetings with team support, such as investigator/coordinator meetings, DMC and SMC meetings, and safety calls.
Assist in developing the investigational product and co-medication strategy, including quantities, labels, depots, and tracking, in collaboration with other departments.
Participate in data review and discrepancy resolution.
Coordinate with internal Pharmacovigilance and safety groups.
Monitor study-specific timelines and key deliverables, with a focus on managing external vendors such as monitoring, sample management, IVRS, and laboratory vendors.
Participate as a member of multidisciplinary trial teams.
Develop relationships with investigational sites and institutions to enhance trial conduct.
Serve as a preliminary liaison for study sites, conveying trial information and answering questions in accordance with the escalation pathway.
Participate in working groups and perform assigned special projects to improve the efficiency, effectiveness, and quality of the Development Operations Department.