Support clinical trial applications submitted via Clinical Trial Information System (CTIS) uploading documents Qin documents uploaded to ensure accurate categorization.
Track CTIS application details to compile metrics
Monitor CTIS notifications received due dates and trends
Identifies system conflicts and resolves or elevates them to management to ensure resolution.
Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
Completes activities to assist in ensuring timely disclosure of accurate consistent aligned and complete information globally.
Communicates deliverables process and timelines effectively across functional areas and within department to accomplish project objectives.
Continually trains/is compliant with all current SOPs & work instructions.
Cross trains with other Trial Disclosure staff.
Requirements:
Bachelors degree required preferably in a health or biological science field.
1-3 yrs experience in clinical trial registries regulatory agency transparency or drug development with a clinical research quality or regulatory background preferably in a pharma industry environment.
Comfortable learning new systems.
Attention to detail. Find and correct errors in spelling punctuation grammar consistency clarity and accuracy.
Ability to shift daily priorities meet deadlines ask questions.
Proficient with major Microsoft suite programs.
Works well in a global team environment.
Available for early hours to support EU colleagues (i.e. start time as early as 7 am CST).
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