Project Support Specialist
hace 3 semanas
We are seeking a highly skilled and detail-oriented Project Support Specialist to join our team at Thermo Fisher Scientific. As a key member of our clinical operations team, you will play a critical role in ensuring the smooth execution of our clinical trials.
Key Responsibilities- Manage metrics in various systems to ensure accuracy and efficiency.
- 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 to minimize inconsistencies in terms of compliance with systems, organizational/customers processes, and procedures.
- Reconcile and oversee systems and trainings for various functional departments, ensuring direct communication with functional leads to follow up and increase training compliance.
- Attend external meetings and teleconferences with clients, supporting the preparation of presentations on Key Performance Indicators (KPI), metrics, status, and possible challenges with systems.
- Provide oversight of metrics in CRG's VV eTMF and Client eTMFs, reconciling file reviews and updating trackers and data repositories as required.
- Assess and analyze results, creating potential action plans suggested to Project Lead/CTM.
- Provide Clarity support with review of actual hours coded each month to identify miscoding, evaluating spend compared to budget.
- Identify risks and communicate in advance to functional leads and client representatives.
- Audit/inspection process awareness with relevant rules and guidance documents.
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
- Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
- Analytical skills, ability to comprehend and analyze data, tables, etc.
- Flexibility to reprioritize workload to meet changing project timelines.
- Knowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycle.
- Advanced English (verbal & written).
- Good computer skills, proficient in several MS Office (Word, Excel, PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
- Strong collaborators, very good communication skills, capable to shift prioritization according to project needs and timelines.
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Transportation Specialist
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