Trial Committee Specialist, Hybrid (Buenos Aires)

About the role

Syneos Health, a fully integrated life sciences services organization, is hiring a Trial Committee Specialist in Buenos Aires, Argentina, working in a hybrid setting. The role covers the end-to-end management of clinical trial committees, from identifying members to supporting adjudication and reporting.

Key responsibilities

• Identify potential members for trial committees and collect and assess their documents (e.g. NDAs, CVs), including debarment checks and conflict of interest attestations.
• Negotiate and execute contractual agreements, and receive, submit and track committee member invoices against the project budget.
• Follow the Committee Charter and project plans: schedule and attend meetings, prepare and distribute agendas, minutes and action items, and track action items.
• Distribute safety listings, expedited safety reports, protocols and other trial documents to members for review.
• Review clinical event and endpoint documentation for completeness of adjudication packages, redaction of PHI, and identification of unreported events requiring adjudication.
• Initiate queries to sites for discrepant or missing data and follow them to resolution.
• Manage translation services, including submission, tracking and assurance of page equivalents on return.
• Support User Acceptance Testing of the committee's collaborative workspace and/or electronic adjudication platform.
• Provide operational support to the Committee Manager on metric reporting, and file trial committee documents in the Trial Master File (TMF).