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Project Support Spec
2 months ago
Ensures project deliverables and targets are met according to the highest quality standards
- Responsible for managing metrics in various systems
- When assigned as Lead, coordinates and supports assigned Project Support Services staff and works closely with funcional leads to ensure optimal operational performance
- Helps study teams to maintain audit readiness by bringing forward innovative ideas and smart new ways of working
- Supports creation, implementation and change management for departmental and cross-functional process improvement/enhancement initiatives
- Supports with risk assessment and analysis to avoid possible deviations and noncompliance with established processes
- Previous experience that provides the knowledge, skills, and abilities to perform the job in a CRO end-to-end project support role.
- Proven experience as a Lead in large or mid-sized projects at least for 1 year - for example, vaccines, COVID, fast track or government studies
- Excellent understanding of project administration tasks, applicable manuals, eTMF and file review processes, client-specific manuals, procedures and requirements
- Experience with different clinical and reporting systems (eTMF, CTMS, LMS), audit preparation, and leading/coordinating global teams is required
- Experience working with different functional leads/functional groups/clients is preferred
- Experience with implementation of client’s systems/processes is preferred
- Experience with:
- leading or coordinating a group
- providing support to different functional leads/functional groups
- active participation in audit preparation
- active collaboration with clients and implementation of client’s systems/processes
- Intermediate to advanced Excel skills (Create tools using different formulas for data comparison and analysis, creating, and updating pivot tables, macros as needed depending on the deliverables) are a strong advantage
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