Senior Clinical Trial Manager

About the role

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.

Essential Functions of the Job (Key responsibilities)

• Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
• Aid 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 7 years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of global clinical trials.
• Able to manage complex and/or large trials.
• Must have non-malignant hematology clinical trial management experience, Von Willebrand disease.
• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
• Able 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.

What ICON can offer you:

• Variety of 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.