Clinical Trial Manager II, Oncology
Job Description:
• 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 within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
• Participate 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 data
• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
• Participate in or lead 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
• Oversee 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 plans
• Participate 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 members
• Provide oversight and direction to trial team members for trial deliverables
• Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
• Ensure quality and completeness of TMF for assigned clinical trials
• Participates in inspection readiness activities including coordination of clinical trial team deliverables
• Participate in the evaluation and implementation of patient-focused 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 range 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 ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Apply Now
Apply Now
• 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 within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
• Participate 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 data
• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
• Participate in or lead 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
• Oversee 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 plans
• Participate 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 members
• Provide oversight and direction to trial team members for trial deliverables
• Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
• Ensure quality and completeness of TMF for assigned clinical trials
• Participates in inspection readiness activities including coordination of clinical trial team deliverables
• Participate in the evaluation and implementation of patient-focused 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 range 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 ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Apply Now
Apply Now