Trial Disclosure Associate

Position Title: Trial Disclosure Associate

Work Location: 100% Remote

Assignment Duration: 2 years

Work Schedule: M-F, available for early hours to support EU colleagues (i.e., start time as early as 7 am CST)

Position Summary:

• Support clinical trial disclosure activities, ensuring timely and accurate information globally.

• Role within Clinical Development Operations (CDO) to manage workload in clinical trial transparency.

• Bachelor's degree required, preferably in a health or biological science field.
• 1-3 yrs experience in clinical trial registries/disclosure with a clinical research or regulatory background, preferably in a pharma industry environment.
• Prior experience working with CTIS or other clinical trial disclosure platforms (like ClinicalTrials.gov, EudraCT, EU CTR).
• Knowledge of EU Clinical Trial Regulation (CTR) and clinical trial disclosure requirements would be preferable.
• Familiarity with clinical trial lifecycle documents (e.g., protocols, ICFs, SAPs, CSR summaries).
• Understanding of redaction and anonymization practices for public trial documents.
• Experience working within a document management system (e.g., Veeva Vault, SharePoint, etc.).
• Comfortable learning new systems. Proficient with major Microsoft suite programs.
• Attention to detail. Find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
• Ability to shift daily priorities, meet deadlines, ask questions.
• 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).

• Support clinical trial applications submitted via Clinical Trial Information System (CTIS), uploading documents, QCing 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 departments to accomplish project objectives.
• Continually trains/is compliant with all current SOPs & work instructions.
• Cross trains with other Trial Disclosure staff.