Local Trial Manager II

3 weeks ago

toronto, Canada ICON Strategic Solutions Full time

ICON is hiring for a Local Trial Manager II position who will be running the Canadian portion of global trials from start up, maintenance, to close out. Responsible for the Canadian trial deliverable. Direct hire, fully remote position, no travel, with starting pay up to $140K Canadian (No bonus) Must currently, or recently, been working for a CRO, Pharmaceutical or Biotechnology Company, have a bachelor’s degree with 3 years of clinical trial management experience If you are interested, please apply Today. This position is filling fast. Responsibilities: Responsible for running the Canadian portion of global trials, working with cross functional teams, trial budget, and trial vendor oversite. Site interaction, training SIV’s, Onboarding, Identification – selection support Responsible for reviewing trip reports. Monitoring plan: Contributed, updated, and made changes Coordinated 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 contributes 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 environment Must have experience with following Monitoring Plans, Site report reviews (trip reports) , CRA and Site interaction and training. Bachelor’s degree & 5 years of directly related experience

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