Clinical Study Delivery Specialist
hace 2 semanas
This role is with ICON plc, an inclusive employer and a member of Mygwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly.
About the Role:As a Study Delivery Specialist, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare. You will provide support to the clinical trial team at the global level, impacting directly on project success.
Key Responsibilities:- Keeping up to date with all changes and required knowledge on ICH GCP, sponsor's written standards, and attending appropriate training sessions.
- Supporting multiple studies simultaneously and prioritizing appropriately to meet business needs to ensure delivery of results.
- Management of access and study trackers, maintaining all study trackers and access, and analyzing various reports.
- Timely distribution of dashboards and reports to the study team and system-related support.
- Managing study systems, TMF management and maintenance, and providing timely follow-up with stakeholders to improve TMF compliance.
- General areas of support, including common email groups to support issues related to CSAP, CTMS, clinical admin support, and archival support.
- Excellent technical/IT skills, with the ability to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of sponsor's systems/software.
- Knowledge of ICH GCP relevant operational procedures, systems, and quality guidelines regarding clinical studies.
- Able to work independently as well as in a team, with a professional attitude and good customer focus (internal and external).
- Time management skills, with the ability to complete system updates and e-TMF in a timely manner.
- Very good communication skills, with a high English level.
- 1-2 years of prior experience in clinical operations as CTA, CPA, or similar, with knowledge of main systems (v-TMF, m-CTMS) and the willingness and ability to continuously learn and become highly competent in using sponsor's evolving systems and tech.
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits, designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
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