Clinical Quality and Training Manager

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.

• Partners with internal experts and Subject Matter Experts (SMEs) within the company to identify and assess learning needs
• Participates in the selection, hiring and training of new QA staff.
• Designs, develops, reviews and revises course materials, interactive and multimedia technology-driven components, and other learning materials.
• Manages project assignments to required timelines and quality standards.
• Leads QA auditors’ team by providing clear team and individual goals and expectations and ensuring that each member of the auditing staff understands her/his responsibility to know and follow all SOPs and corporate policies
• Performs personally and/or ensures contracted and/or internal audits are completed according to client expectations and/or SOPs and audit plans
• Interprets regulations and guidance documents governing GCP and serves as expert and consultant to staff and client representatives
• Performs personally and/or ensures all new and updated SOPs are reviewed by QA
• Performs personally and/or ensures client audits and regulatory inspections of the company are managed to facilitate the client/inspector expectations and minimize disruptions to ongoing operations
• Researches the published information, interacts with QA and/or regulatory professionals and maintains knowledge of current expectations, new trends, and proposed changes to regulations that may impact internal stakeholders.
• Leads the evaluation and management of site specific escalations related to persistent or serious misconduct.
• Participates, as requested, on GCP related projects initiated by internal stakeholders
• Provides regular status reports on quality observations to Operational Management, as requested.

• 5 years experience with auditing, compliance, and SOP development preferred.
• Advanced working knowledge of GxP (GMP, GLP, GCP)
• Ability to translate regulation into creative, practical and interactive training concepts/material
• Experience using Macromedia Flash, Fireworks and Captivate; Adobe Audition and Photoshop, or similar multi-media software packages preferred but not required.
• Understanding of adult learning theory and principles of online development, as well as strong instructional design for web-based and blended learning solutions.
• Experience leading or direct management of staff is preferred.
• Must have thorough understanding of GXP and EC and/or US regulations
• Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies ad clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred
• Read, write and speak fluent English;fluent in host country language required.  Fluency in other languages is a plus.
• An undergraduate degree or its international equivalent from an accredited institution required.  Preferably in the health-sciences or computer sciences.
• Managerial experience in clinical research preferred
• Knowledge of CRO / Healthcare / Pharmaceutical quality assurance activities preferred.

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.