Clinical Trial Manager II (Regulatory experience)

About the role

Syneos Health is seeking a Clinical Trial Manager II with regulatory experience to oversee site management, clinical monitoring and central monitoring activities for trials conducted in Argentina. The role focuses on patient safety, protocol compliance and data integrity.

Key responsibilities

• Provide oversight of site management, clinical and central monitoring deliverables, ensuring GCP and regulatory compliance.
• Manage site interactions from activation through closeout, including recruitment and investigator payments.
• Identify and mitigate risks using the Risk Assessment and Categorization Tool (RACT) and operational metrics.
• Coordinate with functional leaders (Study Start‑Up, Patient Recruitment, Data Management) to meet activation, enrollment and database lock milestones.
• Develop and maintain clinical study tools and templates, set up CTMS, dashboards and oversee user acceptance testing.
• Train study teams on protocol specifics, CRF completion, SOPs and monitoring plans.
• Monitor quality of clinical and central monitoring deliverables through approved systems and dashboards.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent education and experience.
• Proven ability to lead and align cross‑functional teams to achieve project milestones.
• Experience working in an international, remote environment.
• Strong knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.

Required skills

• Clinical Monitoring and Central Monitoring expertise.
• Experience with CTMS, Electronic Data Capture (EDC), eDiary, ePRO, Trial Master File (TMF) and IVRS/IWRS systems.
• Risk‑based monitoring methodology.
• Understanding of clinical trial financial principles and budget management.