Clinical Trial Disclosure Associate
Responsibilities:
- 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:
- Bachelor's 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).