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Clinical Operations Specialist
hace 1 mes
At ICON Strategic Solutions, we're seeking a highly skilled Clinical Operations Specialist to join our team. As a key member of our clinical trial support team, you will play a critical role in ensuring the successful delivery of our studies.
Key Responsibilities:- Stay up-to-date with the latest ICH GCP guidelines and sponsor requirements, attending relevant training sessions as needed.
- Support multiple studies simultaneously, prioritizing tasks to meet business needs and ensure timely delivery of results.
- Manage access and study trackers, analyzing various reports and distributing dashboards and reports to the study team in a timely manner.
- Provide system-related support, including managing study systems, TMF management and maintenance, and common email group support for CSAP and CTMS issues.
- Work closely with the study team to manage activities post-SAC and until final archival.
- Excellent technical and IT skills, with the ability to understand the impact of technology on studies and use and develop computer skills 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.
- Strong time management skills, with the ability to prioritize tasks and meet deadlines.
- Very good communication skills, with a high level of English proficiency.
- 1-2 years of prior experience in clinical operations as a CTA, CPA, or similar role.
- Knowledge 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.
- A competitive salary and a range of additional benefits, including various annual leave entitlements, health insurance offerings, and retirement planning options.
- A global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals.
- A supportive and diverse culture that rewards high performance and nurtures talent.
