ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
We are looking for a dedicated and motivated Clinical Trial Manager to join an well-establish ed team of international clinical study managers for one of the top pharma companies.
Clinical Trial Manager main responsibiliti es will include:
• Planning and management of clinical studies conducted by global development team through the leadership of the cross-function al clinical study team
• Contributing to study-level risk assessments
• Leading and continually review risk mitigation activities to ensure study delivery to plan
• Identifying and resolving issues at a global level
• Reporting study progress at appropriate forums and to management
• Collaborating with Regional Clinical Trial Manager to ensure country level study delivery aligned with global delivery plans
• Overseeing global insourcing/out sourcing partner deliverables to the required standards
• Managing study-level budget and timelines
• Partnering with Tech Services, Supplier Governance and Electronic Trial Operations - to ensure vendor set-up, conduct and quality oversight of deliverables • Leading global study-level documentation and required tool and systems set-up
• Leading development and implementation of global Drug Supply Plan
• Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines
• Ideally able to start ASAP/negotiabl e
What is required:
• BA/BS/BSc or RN
• Previous experience of project managing i nternational/g lobal commercial clinical studies within the clinical research industry, i.e. within pharma, CRO or biotech working environments
• Previous clinical study management/cli nical project management as a Clinical Study Manager
• Experience in overseeing external clinical research vendors (CROs, central labs, imaging vendors, etc.) highly preferred
• Project management experience including oversight of study deliverables, budgets, and timelines
• Ability to use scientific and clinical knowledge to conceptualize study designs
• Experience anticipating and resolving problems
• Experience writing and presenting clearly on scientific and clinical issues
• Experience collaborating and leading cross-function al teams (team/matrix environment)
• Knowledge of project risk management assessment and mitigation approaches
• Full-time availability
• Full and valid driving license
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.