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.ICON plc is a world-leading healthcare intelligence and clinical research organisation.
From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.
ICON people have a mission to succeed and a passion that ensures what we do, we do well.
**General Summary**The Start-Up Lead (SUL)
leads regional clinical study start-up activities to ensure successful activations of investigative sites in accordance with protocol, budget, standard operating procedures, policies and applicable regulations.
Ensures optimal quality delivery for assigned sites' readiness to enroll, meeting sponsor satisfaction to timelines.
Proactively identifies and mitigates risks and resolves issues, escalating appropriately.- Creates, maintains and facilitates Sponsor Approval of project documents related to study start-up, including the Essential Document Templates, Essential Document Review Requirements, Country and Site Standard Investigational Product Release forms.- Creates, maintains and facilitates Client Approval of project status reports.- Prepares and presents a project-specific overview to Clinical Operations, Investigator Grant Management and Global Regulatory Affairs staff regarding start up deliverables, timelines and processes.- Oversees site identification and recruitment activities for allocated countries; including, liaising with other departments when additional sites are needed, and escalates delays,
where applicable.- Oversees the Local Regulatory Affairs Lead (LRAL), Contracts Associate (CA) and In- House Clinical Research Associate (IHCRA) to ensure that essential documents for allocated regions are developed, collected, reviewed and tracked according to the processes and timelines agreed upon on the project.- Collaborates with the Global Regulatory Affairs Lead (GRAL) assigned to the project to ensure Ministry of Health (MoH), Central Independent Ethics Committee (IEC) and other central submissions are performed in line with site activation timelines.- Collaborates with the GRAL and Clinical Team Manager (CTM) assigned to the project to ensure importation, exportation, insurance, labeling of Investigational Product (IP) and any other country requirements are met to ensure the timely activation of trial sites.- Oversees Local Ethics Committee (IEC)
and other local authority submissions and approvals for their country/region or the project as applicable.- During Start-Up, works with GRAL/ LRALs and/or IHCRA(s) to ensure quality amendments and submissions are made (where applicable).- Performs Independent QC of Investigational Product Release packages and other documentation (i.E
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