Clinical Trial Manager: Regulatory & Site Oversight

7050 INC Research Clinical Services Mexico Limited, S.A. de C.V.; México; Híbrido; MXN 700.000 - 1.000.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Clinical Trial Manager with regulatory experience to lead site qualification, initiation, monitoring, and close-out visits across sites, ensuring GCP/regulatory compliance and data integrity. You will coordinate with project teams to resolve issues and support audit readiness.

The role requires a Bachelor’s degree or RN and strong communication skills, with the ability to travel up to 75%.

Formación

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.

Responsabilidades

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remote).
• Ensure regulatory, ICH-GCP and GPP protocol compliance and escalate serious issues to the project team.
• Verifies informed consent, maintains confidentiality, and ensures data integrity in CRFs.
• Records activities with letters and logs per SOPs and monitors audit readiness.

Conocimientos

Regulatory experience

Excellent communication

Interpersonal skills

Computer skills

Travel up to 75%

Educación

Bachelor’s degree or RN

Herramientas

GCP/ICH guidelines knowledge

Descripción del empleo

Syneos Health is seeking a Clinical Trial Manager with regulatory experience to lead site qualification, initiation, monitoring, and close-out visits across sites, ensuring GCP/regulatory compliance and data integrity. You will coordinate with project teams to resolve issues and support audit readiness.

The role requires a Bachelor’s degree or RN and strong communication skills, with the ability to travel up to 75%.