Local Trial Manager (US)

ICON has opened 3 new Local Trial Manager positions (US) (ICON embedded with AstraZeneca) to be hired now with a start date in January. This position will be running the US portion of global trials from start up, maintenance, to close out. Responsible for the US trial deliverable, vendor oversite and budget, following Monitoring Plans, Site report reviews, CRA and Site operational oversite and training, as well as working with cross functional teams. Direct hire, fully remote position, no travel, with starting pay up to $130K (No bonus) The positions will fill fast, so please apply today. Following Monitoring PlansReviewing Site Reports (trip reports)CRA and Site operational oversite and training Local Trial Manager position (ICON embedded with AstraZeneca)Responsibilities:Responsible for running the US portion of global trials, working with cross functional teams, budget, and vendor oversite.Site oversite, training SIV’s, Onboarding, Identification – selection supportResponsible for reviewing trip reports.Monitoring plan: Contributed, updated, and made changesCoordinated cross-functional study teams, CRA’s, CTM’s, IH-CRA’s (Performed CRA interaction oversite, and training, Data Management, Biostatistics, Regulatory, Clinical Development) to drive operational excellence and timely data cleaning activities, data snapshot and data locks.Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).Supports country-level operational planning and accountable for site selection within assigned country/-ies.Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.Supports and contributions to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems.Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study. Responsible for approval of Baseline and Revised Enrolment Plans (Country Level) Qualifications:Minimum 3 years’ experience running local/regional/global trials in a CRO, Pharmaceutical or Biotechnology environmentMust have experience with writing Monitoring Plans, Site report reviews (trip reports) , CRA and Site operational oversite and training.Bachelor’s degree & 5 years of clinical experience