Remote Clinical Trial Manager II (Regulatory)

Syneos Health, Inc.; Buenos Aires; A distancia; ARS 91.394.000 - 137.091.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Clinical Trial Manager II with regulatory experience for Argentina. The role oversees site management, monitoring, risk assessment, and collaboration with cross-functional teams to ensure protocol compliance and data integrity in a remote-capable environment.

You will lead study activities from initiation to closeout, manage budgets, timelines, and relationships with investigators, and contribute to trial optimization using CTMS, EDC, and TMF tools.

Formación

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Demonstrated capability of working in an international environment.
• Demonstrates understanding of clinical trial management financial principles and budget management.
• Must demonstrate good computer skills.
• Good communication, presentation and interpersonal skills among project team and with sites.
• Strong conflict resolution skills.

Responsabilidades

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates to the project manager any risks to clinical trial management deliverables and any activities outside contracted scope.
• Participates and presents in key meetings such as Kick Off Meeting.
• Collaborates with other functional leaders to coordinate delivery handoffs and meet milestones.

Conocimientos

Team leadership

International collaboration

Budget management

Computer skills

Communication

Conflict resolution

Educación

Bachelor’s degree or RN

Herramientas

CTMS

EDC

TMF

eDiary

Descripción del empleo

Syneos Health is seeking a Clinical Trial Manager II with regulatory experience for Argentina. The role oversees site management, monitoring, risk assessment, and collaboration with cross-functional teams to ensure protocol compliance and data integrity in a remote-capable environment.

You will lead study activities from initiation to closeout, manage budgets, timelines, and relationships with investigators, and contribute to trial optimization using CTMS, EDC, and TMF tools.