IHCRA

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.

• Manage and execute the start-up activities in the allocated clinical trials in compliance with EU CTR, local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements to deliver reliable, high quality data and study subject protection to activate sites prior global submission of the trial
• Establish and maintain professional relationships with internal and external stakeholders

Start-up activities:
• Update COSMOS (site and contact set-up), prepare and upload country & site trial documents to Veeva Vault, both until submission
• Prepare Part II and selected Part I documents for submission (incl. translation and redaction) and to handover the CTA package to EU Submission Hub within selected timelines
• Approve labels in the system and directions for use
• Act as a back-up contact for the RA-CTA management
• Check the completeness and correctness of all documents/materials for SIV in close collaboration with the CRA and CDC Clinical Trial Administrator
• Prepare and check if all trial materials (lab kits, BG meters, test strips, ITMF, etc.) are in place before SIV
• Participate in kick-off meetings and trial TCs with the EU Submission Hub and CDC Start-up Trial Managers
• Provide input to submission timelines to EU Submission Hub and CDC Start-up Trial Manager
• Prepare and handover to EU Submission Hub the annual trial report based on an input provided by CDC Trial Manager
• Repeat start-up activities during the trial conduct: to prepare documents for submissions and notifications and handover to EU Submission Hub (incl. translation and redaction of new trial documents)
• Perform assistance and participate in audits and inspections at sites and the affiliate, as applicable
• Monitor and communicate internally any site observations critical to business results
• Cooperate and communicate to EU Submission Hub and CDC Start-up Trial Manager progress and critical issues that may impair trial progress
• Identify potential risks and proactively take action to prevent or mitigate
• Perform any other tasks assigned by the line manager
• Participate in internal working groups, initiatives
• Represent Novo Nordisk in external working groups and at conferences

Master’s degree in Life Sciences or equivalent

Min. 1 year of experience in start-up from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO)

• Therapeutic knowledge as applicable demonstrated understanding of diseases and treatments
• IT proficiency: MS Office, clinical trials systems (e.g. COSMOS, NovoTime, CONNECT, Veeva)
• Fluent English verbal and writing skills

• Ability to build and maintain strong working relationships with internal and external stakeholders
• Team oriented personality with high degree of flexibility - close collaboration with relevant roles to ensure successful start-up of the trial
• Takes ownership of start-up activities to ensure timely submission and FPFV, proactively flags risks and issues and provides possible mitigations and solutions
• High focus on delivery and quality
• Excellent negotiation, communication & presentation skills
• Ability and willingness to adjust quickly to new situations in a continuously developing environment
• High degree of trustworthiness
• Proven decision making and problem-solving capabilities
• Ability to go beyond current responsibilities
• Ability to manage multiple priorities


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.
#LI-OB1

#LI-Onsite