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Clinical Operations Specialist
hace 1 mes
Study Delivery and Management Specialist Role
As a Study Delivery and Management Specialist at ICON, you will be part of the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.
You will provide critical support to the clinical trial team at the global level, directly impacting the project's success.
Key Responsibilities:
- Stay up-to-date with all changes and required knowledge on ICH GCP, sponsor's written standards, and attend relevant training sessions.
- Support multiple studies simultaneously, prioritizing tasks to meet business needs and ensure timely delivery of results.
- Maintain study trackers and access, analyze reports, and distribute dashboards and reports to the study team.
- Manage study systems, including TMF activities for Inhouse and FSO trials, and provide timely follow-up with stakeholders to improve TMF compliance.
- Support studies without SDS requirements, working closely with SDS/SM to manage activities post SAC and until final archival.
Requirements:
- Excellent technical/IT skills, with the ability to understand the impact of technology on studies and use sponsor's systems/software effectively.
- Knowledge of ICH GCP relevant operational procedures, systems, and quality guidelines regarding clinical studies.
- Able to work independently and as part of a team, with a professional attitude and good customer focus (internal and external).
- Very good communication skills, with a high English level.
- 1-2 years of prior experience in clinical operations as CTA, CPA, or similar.
- Knowledgeable of main systems (vTMF, mCTMS) and the willingness and ability to continuously learn and become highly competent in using sponsor's evolving systems and tech.
What ICON Offers:
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.
