Job Details
- Languages
- English
- Experience
- Min. 2 years
- Required Skills
- Project ManagementGCPDocumentationAnalytical Skills
Requirements
- Bachelor's degree required.
- Minimum 2 years relevant industry experience in clinical document management.
- Proven analytical and critical thinking skills.
- Good oral and written communication skills, and ability to facilitate meetings.
- Ability to manage several projects simultaneously.
- Competent knowledge of clinical documentation business procedures.
- Ability to work independently in clinical documentation systems.
Responsibilities
- Ensures real-time inspection readiness of clinical documentation and TMF by performing quality control.
- Collaborates with artifact owners and holds team members accountable for TMF sections.
- Provides regular status updates and leads TMF meetings.
- Develops and maintains study-specific TMF structure documentation.
- Prepares TMFs for audits and inspections, contributing to continuous improvement projects.
