[Remote] Clinical Trial reputed company (Clinical Project ...

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a world-leading reputed company intelligence and clinical research organization. The Clinical Trial reputed company will manage the day-to-day operations of assigned trials, ensuring compliance with regulatory requirements and leading cross-functional teams to reputed company project goals. Responsibilities • Manage and reputed company the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements • Manage and reputed company cross-functional trial teams, including vendor set-up, performance reputed company and closeout activities • Responsible for reputed company and guidance to clinical study team members in completing deliverables according to agreed timelines and reputed company standards, including awareness and escalation of high reputed company reputed company-reputed company topics for assigned studies • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for reputed company trial team members • reputed company or reputed company development of reputed company study documents, study plans and systems set-up to ensure operational reputed company in execution of the clinical trial protocol and reputed company across investigative sites, vendors and data • Proactively identify and resolve issues that reputed company during trial conduct; manage escalation of trial-reputed company issues, internally and externally • reputed company input on clinical operational/development reputed company for interactions with regulatory authorities and key opinion leaders, either globally or regionally • reputed company preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of reputed company vendors; effectively manage interactions with vendor project management team • reputed company feasibility assessment and selection of countries and sites for trial conduct • Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables • Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate reputed company and reputed company completion of trials and deliverables according to established objectives, milestones and goals • reputed company accurate and up-to-date trial information in relevant tracking systems and reputed company regular updates of trial progression to the Clinical Operations reputed company and other defined stakeholders • Participates in inspection readiness activities including coordination of clinical study team deliverables • Individuals may serve in regional reputed company to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable • Individuals may reputed company regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations reputed company, to optimize global development reputed company • Facilitate and manage regional KOL interactions, as applicable • reputed company the clinical aspects of reputed company data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings • Participate in process improvement and reputed company-reputed company initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct • reputed company reputed company and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-reputed company strategies for assigned trials, globally and regionally, as appropriate • Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials Skills • BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements • Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring with a reputed company on cross-functional team reputed company • Requires proven project management skills and trial leadership ability • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability • Phase I oncology experience required • Global experience required (Experience working with China preferred) • Must be reputed company to working PST time as required • Moderate (~25%) travel required Benefits • Various annual leave entitlements • A reputed company of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years reputed company. • Global Employee Assistance Programme, reputed company, offering 24-hour reputed company to a global network of over 80,000 in

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