Clinical Trial Manager (CMO) - Post-Trial Access

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

What you will be doing:

• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
• Participate as a member of working groups and perform special projects, as assigned.
• Function as the primary contact for program(s) between Drug Development and other departments.
• Lead multi-disciplinary trial teams, including study team meetings.
• Assist with CRA and third-party vendor training on protocols and practices.
• Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work.
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with program team.
• Participate in monitoring study/program safety.
• Develop risk-mitigation plan, and implement contingencies as required.
• Ensure appropriate clinical trial supply plans are implemented and managed.
• Generate reports to update management on the progress of the trial(s).
• Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
• Participate in data review and discrepancy resolution as needed
• Develop and manage trial(s) timelines, budgets, and priorities.
• Select, coordinate and monitor activities of vendors. Review of monitoring reports and conduct co-monitoring visits, as needed.
• Lead the evaluation and selection of investigative sites, responsible for feasibility.
• 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.
• Accountable to deliver trial(s) on time, within budget, and with highest achievable quality.

You are:

• BS/BA degree or a relevant degree with strong emphasis on science or equivalent experience

• Minimum of four years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct, management, and especially closeout and termination of multinational clinical studies with a focus on skills and competencies rather than specific years of experience.
• Experience in the biopharmaceutical industry or other relevant global clinical research programs in the initiation and management of continued access/post-trial access programs
• Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.
• Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.
• Experience working in a multidisciplinary setting, strong collaborative team player, with the ability to be flexible and adapt to a changing environment.
• Experience in executing a wide range of clinical program activities
• Demonstrate leadership and problem-solving skills.
• Ability to effectively manage multiple priorities across several programs and therapeutic areas simultaneously.
• Familiarity with lean six sigma concepts and methodologies is preferred
• Experience with Medical Affairs/Post-Trial Access is required
• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.

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.