Clinical Trial Results Manager
Core
Manage the creation, review, approval, and public disclosure of clinical trial results data and forms to regulatory databases and public platforms.
Role type
Clinical Trial Results Manager
Builds
Clinical trial results reporting forms, AE XML files, and public disclosures on ClinicalTrials.gov/EudraCT/CTIS
Domain
Clinical research / Regulatory compliance
Required skills
Clinical study report analysis, Results form creation, Regulatory database management, Statistical liaison, Protocol impact assessment, Scientific writing
Preferred skills
Quality/Regulatory/Compliance experience, Clinical trial protocol familiarity
Technologies
ClinicalTrials.gov, EudraCT/CTIS, Excel
Responsibilities
Identify result summary data to be disclosed based on protocol and study report; Create results reporting forms; Manage review and approval process for forms; Upload approved forms to ClinicalTrials.gov and EudraCT/CTIS; Partner with DQS and external partners to create and upload AE xml files; File reporting extensions (certificates of delay); Liaise with Statisticians, Physicians, Patent Attorneys, and Medical Writers; Assess revised protocols for impact on registration; Publish CSR synopsis; Support Plain Language Summary activities.
Seniority
Mid-level, hands-on IC