Clinical Operations Specialist
hace 4 semanas
Job Overview
We are seeking a highly skilled Clinical Operations Specialist - Project Support to join our team at Thermo Fisher Scientific.
About the Role
This is an exciting opportunity to work in a dynamic and growing organization, where you will be responsible for managing metrics in various systems, coordinating with study teams, and ensuring optimal operational performance.
Your Key Responsibilities
- Coordinate and support assigned PSS staff and work closely with functional leads to ensure optimal operational performance.
- Help study teams maintain audit readiness by bringing forward innovative ideas and smart new ways of working.
- Support creation, implementation, and change management for departmental and cross-functional process improvements/enhancements initiatives.
- Support risk assessment and analysis to avoid possible deviations and noncompliance with established processes.
- Provide end-to-end oversight and follow-up on study level activities aiming to minimize any inconsistencies in terms of compliance with systems, organizational/customers processes, and procedures accurately applied at all levels.
- Provide reconciliation, oversight, and follow-up on systems and trainings for various Functional Departments. Direct communication with Functional Leads to follow up and increase training compliance >99% on study level.
- Attend (if required) external meetings & teleconferences with clients. Supports with preparation of presentations including information about Key Performance Indicators (KPI), metrics, status, and possible challenges with systems.
- Provide oversight of metrics in CRG's VV eTMF and Client eTMFs; reconciliation of File Reviews.
- Update and maintain trackers and data repositories as required.
Requirements
We are looking for a candidate with a strong understanding of PSC tasks, applicable PSCs' and other manuals, eTMF and File Review processes, client-specific manuals, procedures, and requirements. You should also have knowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycle, and advanced English skills. Additionally, you should possess good computer skills, proficient in several MS Office tools, and ability to obtain knowledge and master all clinical trial database systems.
What We Offer
In addition to a competitive salary ($85,000 - $115,000 per year), we offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
How to Apply
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