We are looking to bring an experienced Centralized Study Specialist to our team in Bulgaria.
Responsibilities will include:
- Review initial/amended Country/Site ICFs in compliance with Sponsor requirements local regulatory requirements and Good Clinical Practice (GCP) guidelines
- Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
- Support system compliance and system data entry as applicable
- File required task-related documentation in the Electronic Trial Master File (eTMF)
The critical skills were looking for:
- Scientific degree is preferred
- Strong attention to detail
- Clear and effective communication
- Flexibility in managing review timelines and shifting priorities
- Solid understanding of the ICF process is a plus
- Previous experience in a centralized role (working across multiple regions) is a plus
Learn more about our EEO & Accommodations request here.
Required Experience:
IC
We are looking to bring an experienced Centralized Study Specialist to our team in Bulgaria.Responsibilities will include:Review initial/amended Country/Site ICFs in compliance with Sponsor requirements local regulatory requirements and Good Clinical Practice (GCP) guidelinesReview and implementatio...
We are looking to bring an experienced Centralized Study Specialist to our team in Bulgaria.
Responsibilities will include:
- Review initial/amended Country/Site ICFs in compliance with Sponsor requirements local regulatory requirements and Good Clinical Practice (GCP) guidelines
- Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
- Support system compliance and system data entry as applicable
- File required task-related documentation in the Electronic Trial Master File (eTMF)
The critical skills were looking for:
- Scientific degree is preferred
- Strong attention to detail
- Clear and effective communication
- Flexibility in managing review timelines and shifting priorities
- Solid understanding of the ICF process is a plus
- Previous experience in a centralized role (working across multiple regions) is a plus
Learn more about our EEO & Accommodations request here.
Required Experience:
IC
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