Trial Activation Approval Specialist I
Trial Activation Approval Specialist I
Posted on :
10-05-2025
Employer Active
1 Vacancy
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
- Facilitate site startup and communication with internal and external team members to ensure flawless site approval and study timelines.
- Support sites and study teams to achieve rapid site startup.
- Work directly with assigned sites on all essential document collection and review.
- Partner with internal Study Startup team CROs Clinical Operations teams and TAU partners to improve overall SSU metrics and processes.
- Ensure standards are strictly applied to the SSU processes across projects.
- Review essential documents for startup including ICF FDF 1572 CVs etc.
- Quickly identify potential site activation delays and bring up to appropriate team members.
- Track actions and communications with sites to ensure timelines are met.
- Support resolving advanced issues identified by CROs and Clinical Operations teams in partnership with the internal Study Startup team.
- Review and provide feedback to management on site performance metrics.
- Ensure accuracy and completeness of the eTMF for assigned sites during startup.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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