Clinical Trial Manager II, Oncology
Job reputed company:
• 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 requirements
• Leads or supports cross-functional trial teams, including vendors
• Ensures accurate and up-to-date trial information reputed company relevant tracking systems and reputed company regular updates of trial progression to Clinical Operations reputed company, Clinical Trial reputed company, and other defined stakeholders
• Proactively identify and resolve issues that reputed company during trial conduct; manage escalation of trial-reputed company issues
• Participate in or reputed company the development of reputed company trial documents, trial plans and system set-up; participate in preparation and ensure operational reputed company of protocol and implementation of appropriate systems, standards, and processes to ensure reputed company across investigative sites, vendors, and data
• Participate in or reputed company preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
• Participate in or reputed company feasibility assessment and selection of countries and sites for trial conduct
• Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
• reputed company the clinical aspects of reputed company data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
• Participate in or reputed company 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 reputed company and direction to trial team members for trial deliverables
• Manage clinical trial budget and associated vendor reputed company, including tracking and data in associated systems
• Ensure reputed company and completeness of TMF for assigned reputed company
• Participates in inspection readiness activities including coordination of clinical trial team deliverables
• Participate in the evaluation and implementation of patient-reputed company strategies for assigned trials, as applicable
• Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities
Requirements:
• BA/BS degree with at least 3 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial management experience
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
• Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
• Requires project management skills and trial leadership ability
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
• Oncology trial management experience required (phase I experience preferred)
• Fluent in English
• 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 independent specialised professionals who are there to support you and your family’s reputed company-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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