Clinical Trial Manager - Expanded Access Programs

As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Clinical Trial Manager provides input to the overall operational trials(s) planning and implementation, manages program(s) timelines and budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and external vendors.

What you will be doing:

• Deliver Trials(s) on time, within budget, and with highest achievable quality.
• Assist in the review, development and/or writing of clinical trial documents and manuals as needed, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
• Manage the evaluation and selection of investigative sites for applicable clinical trials, responsible for feasibility.
• Select, coordinate, and monitor activities of vendors.
• Review of monitoring reports and conduct co-monitoring visits, as needed.
• Develop and manage trial(s) timelines, budget and priorities.
• Participate in data review and discrepancy resolution.
• Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
• Generate reports to update management on progress of the clinical trial(s)
• Ensure appropriate clinical trial supply plans are implemented and managed where appropriate
• Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
• Participate in monitoring study/program safety.
• Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
• Perform initial review of CRO and other third-party vendor training on protocols, guidelines, and/or practices.
• Lead multi-disciplinary trial teams, including the study team meetings.
• Function as the primary contact for program(s) between Drug Development and other departments

You are:

• BS/BA degree or a relevant degree with strong emphasis on science or equivalent experience.
• Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management, and especially post trial access
• Experience in the biopharmaceutical industry or other relevant global clinical research programs in the initiation and management of continued access/post-trial access programs
• Ability to manage complex and/or large clinical/medical programs.
• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
• Ability to effectively manage multiple priorities across several programs and therapeutic areas simultaneously.
• Demonstrated leadership and problem-solving skills.
• Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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