Clinical Trial Manager

Remote • Full-time

About the role

Manage Phase I oncology clinical trials, ensuring completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

Responsibilities

• Manage the day-to-day operations of assigned trials and responsibilities
• Lead or support cross-functional trial teams, including vendors
• Ensure accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to 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; 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 facilitate 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
• Participate 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 of clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 years of clinical trial management experience
• Strong knowledge of ICH/GCP guidelines and regulatory requirements
• Knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
• Project management skills and trial leadership ability
• Excellent interpersonal, written, and verbal communication skills, administrative skills, and computer ability
• Fluent in English
• Experience in Phase I oncology
• Global experience with primary focus on independent vendor set-up and management, oncology cohort management, and experience in supporting dose escalation safety meetings
• May be asked to work East Coast hours if located further West
• Moderate (~25%) travel required
• Employment contingent upon having the legal right to work in the country where the role is based

Benefits

• Competitive base salary and performance-related incentives
• Health and wellbeing programs including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programs and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Pay

$110,000 - $130,000 / year