Clinical Operations Specialist
hace 4 semanas
Key Responsibilities:
As a Study Delivery Specialist, you will be part of a global team that supports clinical trials. Your primary focus will be on providing support to the clinical trial team at the global level, impacting the project's success.
Key Tasks:
- 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.
- Maintaining all study trackers and access, analyzing various reports, and timely distribution of dashboards and reports to the study team.
- Managing study systems, TMF Management and Maintenance, and managing TMF activities both for In-house and FSO trials.
- Providing timely follow-up with stakeholders to improve TMF compliance.
- Supporting studies where there is no requirement of SDS Archival support, working closely with SDS/SM to manage activities post SAC and till final archival.
Requirements:
Excellent technical/IT skills, able to understand the impact of technology on studies and 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, professional attitude with good customer focus (internal and external), and time management as system updates, eTMF, etc. need to be done in a timely manner.
Very good communication skills - 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 Can Offer:
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.
Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.
Our Benefits Examples Include:
- Various annual leave entitlements.
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
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