Perform tasks in support of Clinical Trial Submission Coordinators and Regulatory CTA SM and GCO country teams to make all clinical trial initial submissions, amendment submissions and notifications in CTIS and track their progress
Job Summary
Perform tasks in support of Clinical Trial Submission Coordinators and Regulatory CTA SM and GCO country teams to make all clinical trial initial submissions, amendment submissions and notifications in CTIS and track their progress.
Assist in study specific submissions document management, document collation, and perform document quality and completeness checks.
Ensure the current submission status and tracking of related information is always available in the appropriate clinical trial management system(s) (CTMS).
Matching Summary
Perform tasks in support of Clinical Trial Submission Coordinators and Regulatory CTA SM and GCO country teams to make all clinical trial initial submissions, amendment submissions and notifications in CTIS and track their progress.
Skills & Requirements
Must-have
Clinical trial submission management
Document collation and quality checks
CTIS submission and archiving
CTMS status tracking
Submission timeline tracking
Nice-to-have
Collaboration with cross-functional teams
Attention to detail and accuracy
Proactive communication and support
Key Requirements
1 year clinical research experience
Equivalent combination of education, training and experience