Clinical Trial Manager

Clinical Trial Manager

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 Clinical Trial Manager is responsible for overseeing the full lifecycle of assigned clinical trials, including planning, execution, and coordination of trial activities. This role leads trial teams, manages communications across stakeholders, ensures timely start-up and conduct of clinical activities, monitors trial progress and quality, manages budgets, supports recruitment and retention plans, supervises clinical supplies, and maintains audit and inspection readiness.

What you will be doing:

• Overall project management of assigned clinical trials

• Responsible for deliverables and high-quality execution of clinical trials

• Leading the trial teams

• Planning, executing, coordinating tasks and communication between relevant roles, such as CTAs and CRAs in adjacent affiliates and global trial management, to facilitate the progress of the trial

• Attending all trial related meetings/TCs and ensuring knowledge sharing across the trial team

• Proactive risk identification and executing mitigation plans

• Ensuring successful start-up of clinical activities (all trial related documents review, CTA dossier oversight, ensure timely HA/EC submission/approval, ensure materials for site initiation/selection, e.g. preparing presentations)

• Responsible for trial budgets: preparation and tracking

• Execute and follow up on Recruitment and Retention plans

• Perform Visit Report review (all types of visits)

• Conduct co-monitoring visits

• CTMS set-up & update at the country level

• Supervise clinical supplies' processes, e.g. ordering, handling ancillary, import-export process

• Report timely on quality issues

• Audit readiness, audit action plans and follow up for assigned clinical trials

• Inspection readiness and inspection action plan for assigned clinical trials

Your Profile:

• BA/BS/BSc or RN, with Master level education preferred

• Fluency in English - written and spoken

• Level of experience:

• Level 1: Minimum 3 years of experience in operational aspects of planning and conducting clinical trials

• Level 2: Minimum 5 years of experience in operational aspects of planning and conducting clinical trials. Minimum 1 year (preferably 2 years) of experience in project management of clinical trials at regional level (e.g. multi country set-up)

• Level 3: Minimum 7 years of experience in operational aspects of planning and conducting clinical trials. Minimum 4 years of experience in project management of clinical trials at regional level (e.g. multi country-set up.

• Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and application international regulations and guidelines

• Clinical Development process and procedures

• Project planning experience including oversight of study deliverables, budgets and timelines

• Ability to apply scientific and clinical knowledge to clinical research

• Experience anticipating and resolving problems

• Experience writing and presenting clearly on scientific clinical issues

• Experience collaborating and leading cross-functional teams (team/matrix environment)

• Knowledge of project risk management assessment and mitigation approaches

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.

Are you a current ICON Employee? Please click here to apply