Pra Health Sciences: Global Trial Leader

Detalles de la oferta

.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 organisations. 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.Responsibilities What you will be doing:The GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The GTL is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document (PED) to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results. The GTL is responsible for leading the cross-functional Trial Team (including GCDO and non-GCDO members) and interfaces with all trial team members, building the trial operational plan, is responsible for ESP contracts and budget, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team (CT)s objectives.The GTL provides global operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof. The GTL maintains oversight of the trial by taking an operational leadership role in a matrix organization, while scientific leadership is provided by the Study Responsible Physician. This includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making. Leads the cross-functional Trial Team; Tracking of Project Deliverables & Timelines using Functional Planning tools and support. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs). Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs.Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract. Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within timelines


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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