CTA

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 searing for a Clinical Trial Assistent

You will provide support (administrative, logistic and document management) in the preparation and execution of all study related activities within agreed timelines.

Major accountabilities

• Specialists responsible for administrative management of trials (In collaboration with CSMs and CRAs, responsible to set-up and keep country and site TMFs continuously up to date according to regulatory and Novartis requirements.)
• Responsible for the preparation, tracking, processing of all study related documentation and material
• Manages logistics and document exchange between clinical sites and our company
• Updates clinical study management systems
• Works in continuous collaboration with other associates/team members
• Applies company policies and procedures to resolve routine issues.
• Contacts are primarily with immediate supervisor and other personnel in department or group
• Works on problems of routine scope. Follows established policies and procedures.
• Normally receives detailed instructions on all work

Clinical Trial Supplies

• Assists local trial team with the creation, ordering, and mailing of any study tools including recruitment materials as well as newsletters, email communications, faxes, etc.
• Supports local trial team with ordering/tracking/mailing of any necessary trials supplies including the regulatory binder, lab kits.
• Support the CSM with the coordination of internal and external suppliers, including customs, to ensure import of all clinical trial supplies (including drug supply)
• Coordinate shipment of clinical trial supplies to local sites
• Co-ordinate relabeling of IMP at warehouse when needed.

Finance:

• Track, process and release payments to vendors in collaboration with local study team and finance.

• A degree or equivalent in a scientific of health care discipline.
• Understand and apply medical and business knowledge to clinical trial execution
• At least 5-6 years’ experience in clinical research
• Solid understanding of clinical trial design, trial execution and operations
• Knowledge of international standards (GCP), international (FDA, EMEA) and local regulations
• Expertise in communication, managing multiple priorities and computer literacy
• Excellent interpersonal skills, proven people management skills with demonstrated good expertise in teamwork.
• Collaboration across boundaries and cross-cultural experience
• Operations Management and Execution

• Languages Dutch, English

• Minimum 5-6 years of experience in clinical research (GCP, ICH Guidelines and Country regulatory environment)

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.