As a Study Start -up Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
In this role you will manage and execute the start-up activities in the allocated clinical trials in compliance with EU CTR, local regulations, ICH-GCP, procedures and protocol requirements to deliver reliable, high quality data and study subject protection to activate sites prior global submission of the trial.
This is a single sponsor dedicated role to 5th largest pharma company by market value.
What you will be doing:
- Update the system, 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 cluster Clinical Trial Administrator
- Prepare and check if all trial materials are in place before SIV
- Participate in kick-off meetings and trial TCs with the EU Submission Hub and cluster Start-up Trial Managers
- Provide input to submission timelines to EU Submission Hub and cluster Start-up Trial Manager
- Prepare and handover to EU Submission Hub the annual trial report based on an input provided by cluster 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 cluster Start-up Trial Manager progress and critical issues that may impair trial progress
- Identify potential risks and proactively take action to prevent or mitigate
You are:
- Bachelor or Master's degree in Life Science or equivalent
- Minimum 1 year of experience in start-up from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO)
- CTAs with start- up experience are very welcome
- 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
Why 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.
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.
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, colour, 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.
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.
