Clinical Trial Manager

Icon • Remote, OR

392d

About The Position

As a Clinical Trial Manager at ICON, you will be responsible for overseeing the delivery of clinical trials on time, within budget, and with the highest quality standards. This role involves managing trial timelines, budgets, and vendor activities, as well as ensuring compliance with regulatory requirements and Good Clinical Practice. You will lead multidisciplinary teams, participate in data review, and develop recruitment and risk-mitigation plans, all while fostering a diverse and inclusive work environment.

Requirements

• BS/BA degree or relevant degree with strong emphasis on science.
• Minimum of four years of experience in the biopharmaceutical industry or relevant clinical research experience in multinational clinical trials.
• Experience managing complex and/or large trials.
• Oncology experience is required; dermatology experience is a nice to have.
• Working knowledge of ICH Good Clinical Practices and relevant regulatory/health authority experience.
• Ability to manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Demonstrated leadership and problem-solving skills.
• Experience executing a wide range of clinical trial activities from initiation to clinical study report.
• Ability to work in a multidisciplinary setting and adapt to a changing environment.
• Strong planning, prioritization, problem-solving, and organizational skills; customer-oriented and able to work independently.
• Strong communication skills to engage with a broad range of stakeholders.

Nice To Haves

• Experience in EAP (Expanded Access Program)/PTA (Post-Trial Access) is preferred.

Responsibilities

• Deliver trials on time, within budget, and with high quality.
• Assist in the review and development of clinical trial documents and manuals.
• Manage the evaluation and selection of investigative sites and feasibility studies.
• Select, coordinate, and monitor activities of vendors.
• Review monitoring reports and conduct co-monitoring visits as needed.
• Develop and manage trial timelines, budgets, and priorities.
• Participate in data review and discrepancy resolution.
• Set up and maintain systems to plan and implement trials and track progress.
• Generate reports to update management on trial conduct.
• Ensure appropriate clinical trial supply plans are implemented and managed.
• Develop recruitment plans and risk-mitigation plans, monitoring and implementing contingencies as required.
• Participate in monitoring study safety.
• Develop key study quality metrics and determine appropriate actions with the study team.
• Perform initial review of CRO and third-party vendor invoices to ensure compliance with scope of work.
• Assist with CRA and third-party vendor training on protocols and practices.
• Lead multi-disciplinary trial teams and conduct study team meetings.
• Function as the primary contact for trials between Drug Development and other departments.
• Participate in working groups and special projects to improve efficiency and quality in Development Operations.
• Ensure adherence to Good Clinical Practice and applicable regulations.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme
• Life assurance
• Flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree