Incyte
Clinical Operations Lead/ Senior Clinical Operations Lead
Incyte, Poland, New York, United States
Clinical Operations Lead / Senior Clinical Operations Lead
Overview : The Clinical Operations Lead supports the Clinical Trial Manager and the operational team in the execution of clinical trials, serving as a liaison with CROs and ancillary vendors to manage operational tasks. The role ensures effective communication with the project team through oral and written correspondence, status reports, and aligns quality, budget, and timelines with study objectives.
Assists 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; review and approve site changes (in consultation with legal and safety when warranted); update template for new risks and amendments.
Participate in the feasibility and evaluation of investigative sites; working closely with the Clinical Trial Logistics group.
Coordinate and monitor activities at investigational sites; review monitoring trip reports and support monitoring organization.
Assist in developing and managing study timelines and priorities, including recruitment tools/strategy and patient retention plans.
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety calls).
Assist in developing the IP and co‑medication strategy (quantities, labels, depots, tracking) working closely with other departments.
Participate in data review and discrepancy resolution.
Participate in coordinating efforts with internal Pharmacovigilance and safety groups.
Monitor study‑specific timelines and key deliverables; focus on managing all external vendors (e.g., monitoring, sample management, IVRS, laboratory).
Act as a member of the multi‑disciplinary trial team.
Develop relationships with investigational sites and institutions to enhance trial conduct.
Serve as preliminary liaison for study sites to convey trial information, answer questions, and follow the escalation pathway.
Assume responsibility to participate as a member of working groups and perform special projects to improve efficiency, effectiveness, and quality of the Development Operations Department.
Requirements
BS/BA degree or a relevant science degree.
Minimum of three years of experience in the biopharmaceutical industry (Senior COL 5+ years) 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.
Prior experience 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.
Seniority level : Mid‑Senior level
Employment type : Full‑time
Job function : Management and Manufacturing
Industries : Pharmaceutical Manufacturing
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Assists 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; review and approve site changes (in consultation with legal and safety when warranted); update template for new risks and amendments.
Participate in the feasibility and evaluation of investigative sites; working closely with the Clinical Trial Logistics group.
Coordinate and monitor activities at investigational sites; review monitoring trip reports and support monitoring organization.
Assist in developing and managing study timelines and priorities, including recruitment tools/strategy and patient retention plans.
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety calls).
Assist in developing the IP and co‑medication strategy (quantities, labels, depots, tracking) working closely with other departments.
Participate in data review and discrepancy resolution.
Participate in coordinating efforts with internal Pharmacovigilance and safety groups.
Monitor study‑specific timelines and key deliverables; focus on managing all external vendors (e.g., monitoring, sample management, IVRS, laboratory).
Act as a member of the multi‑disciplinary trial team.
Develop relationships with investigational sites and institutions to enhance trial conduct.
Serve as preliminary liaison for study sites to convey trial information, answer questions, and follow the escalation pathway.
Assume responsibility to participate as a member of working groups and perform special projects to improve efficiency, effectiveness, and quality of the Development Operations Department.
Requirements
BS/BA degree or a relevant science degree.
Minimum of three years of experience in the biopharmaceutical industry (Senior COL 5+ years) 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.
Prior experience 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.
Seniority level : Mid‑Senior level
Employment type : Full‑time
Job function : Management and Manufacturing
Industries : Pharmaceutical Manufacturing
#J-18808-Ljbffr