The Clinical Trial Transparency function is responsible for clinical trial disclosure and data sharing activities. Executes registration and results disclosure and data sharing activities in accordance with sponsor requirements and international regulations. Participates on project teams to provide guidance on public disclosure and data sharing processes and requirements, including regulatory requirements for content and format
Participates in/leads the evaluation of clinical trial protocols and amendments and applies knowledge of disclosure requirements to develop overall disclosure decision guidance. • Coordinates registration/results disclosure/data sharing submissions. • Oversees maintenance of registration/results disclosure and websites/portals. • Consults with government agencies to resolve submission queries. • Audits publicly disclosed
• information to ensure information is updated appropriately and is in compliance with applicable regulations. • Participates in industry committees to develop strategy, best practices and methodologies to clinical trial data transparency and to align with industry standards. • Manages the redaction of documents and generation of redaction justification tables, if applicable, to support Regulatory Policies and other document/data access regulations or publication requirements as needed. • Manages redacted document postings and submissions, as applicable • Leads implementation and usage of disclosure systems. • Creates and maintains tools to forecast necessary resources. • Reviews registration/results disclosure reports and identifies irregularities. • Develops and updates systems used for registration and results disclosure process. • Projects registration/results disclosure and data sharing of studies according to laws and sponsor policies. • Establishes and maintains relationships with key stakeholders. • Ensures submissions for documents to be translated based upon lower level employee findings for changing law and requirements. • Trains lower level team members as needed
3-5 years of relevant experience. Equivalent combination of education, training, and relevant experience may be considered in place of the education. Bachelor’s degree in relevant field of study. Master’s degree preferred
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.