Senior Clinical Trial Manager

Clinical Trial Manager - Hematology / Von Willebrand Disease

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Sr Clinical Trial Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, functions as the primary liaison for internal stakeholders and vendors leads multidisciplinary departments initiatives, and provides support for process changes to increase efficiency in study executions.

Essential Functions of the Job (Key responsibilities)

• Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.

• Assist in the review, development and/or writing of clinical trial documents and manuals, 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; 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 conduct of trial.

• Ensure appropriate clinical trial supply plans are implemented and managed.

• Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.

• Participate in monitoring study 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 study vendor invoices to ensure that work is performed in accordance with scope of work.

• Assist with CRA and third party vendor training on protocols and practices.

• Lead the multi-disciplinary trials teams; include the study team meetings.

• Function as the primary contact for trial(s) between Drug Development and other departments.

• Assume responsibility to participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.

• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

What you need to have:

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

• Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.

• Able to manage complex and/or large trials.

• Must have non-malignant hematology clinical trial management experience.

• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.

• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

• Demonstrate leadership and problem-solving skills.

• Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).

• Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment.

• Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.

• Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.

• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, color, 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 or submit a request here

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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