Job Title

What you will be doing:Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirementsLeads or supports cross-functional trial teams, including vendorsEnsures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholdersProactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issuesParticipate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and dataParticipate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial teamParticipate in or lead feasibility assessment and selection of countries and sites for trial conductParticipate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverablesOversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plansParticipate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team membersProvide oversight and direction to trial team members for trial deliverablesManage clinical trial budget and associated vendor contracts, including tracking and data in associated systemsEnsure quality and completeness of TMF for assigned clinical trialsParticipates in inspection readiness activities including coordination of clinical trial team deliverablesParticipate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicableResponsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities