Trial Committee Specialist (Clinical Trials) - Hybrid in Belgrade

About the role

Syneos Health is hiring a Trial Committee Specialist for a hybrid position in Belgrade, Serbia. The role covers the end-to-end setup and operation of clinical trial committees, from identifying members and managing contracts to running meetings, reviewing clinical data and supporting the Committee Manager.

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 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 distribute safety listings, expedited safety reports and protocols.
• Review clinical event and endpoint documentation for completeness, redact protected health information and flag unreported events, then initiate queries to sites and follow them to resolution.
• Manage translation services, including submission, tracking and assurance of page equivalents.
• Support User Acceptance Testing of the committee's collaborative workspace or electronic adjudication platform.
• Provide operational support to the Committee Manager on metric reporting and file all trial committee documents in the Trial Master File (TMF).

Required profile

• Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing or a related field, or an equivalent combination of education and experience.
• Previous experience in study coordination or within a CRO, pharmaceutical or biotechnology company preferred.
• High level of written and spoken English; willingness to travel approximately 5% preferred.

Required skills

• Knowledge of Good Clinical Practice (GCP) and ICH guidelines, and other applicable regulatory requirements.
• Proficiency in Microsoft Office.
• Strong organizational and time management skills, attention to detail and excellent communication skills.