Clinical Operations Specialist
hace 4 semanas
Job Summary:
We are seeking a highly skilled Clinical Operations Specialist to join our team. As a Study Delivery Specialist, you will play a critical role in supporting the clinical trial team at the global level, 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 delivery of results.
- Maintain study trackers and access, analyze reports, and distribute dashboards and reports to the study team in a timely manner.
- Manage study systems, TMF, and provide timely follow-up with stakeholders to improve TMF compliance.
- Provide general support, including email group management, clinical admin support, and archival management.
Requirements:
- Excellent technical and 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.
- Strong communication skills, with a high level of English proficiency.
- 1-2 years of prior experience in clinical operations as CTA, CPA, or similar.
What We Offer:
Our success depends on the quality of our people. We offer a competitive salary, a range of benefits, and opportunities for well-being and work-life balance.
Benefits:
- Annual leave entitlements.
- Health insurance offerings.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme.
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