Regulatory-Savvy Clinical Trial Manager

Syneos Health; México; Presencial; MXN 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Clinical Trial Manager with Regulatory experience to oversee site qualification, initiation, monitoring and close-out activities in Mexico. The role ensures GCP/ICH compliance, manages data quality, and coordinates with sponsors across the trial lifecycle.

The candidate should have a bachelor’s degree in life sciences, strong regulatory knowledge, and excellent communication skills.

Formación

• Bachelor's degree in a life sciences field or equivalent.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.
• Excellent communication and interpersonal skills; ability to travel up to 75%.
• Proven ability to manage clinical trial site activities and oversight.

Responsabilidades

• Performs site qualification, initiation, monitoring, management and close-out visits, on-site or remote, ensuring protocol/regulatory compliance.
• Verifies informed consent and protects subject confidentiality; assesses safety and data integrity.
• Manages CMP/SMP activities: source data review, CRF data quality, query resolution and timelines.
• Oversees IP inventory, labeling, import/export and accountability according to protocol.
• Maintains Investigator Site File integrity and archiving per regulations; supports recruitment and site communications.
• Documents activities and supports audit readiness; coordinates sponsor meetings and training as needed.
• Provides site-level scope, budget and timeline management; adapts to changing priorities under Lead CRA guidance.
• Acts as liaison with project sites and ensures training/compliance across teams.
• Contributes to study planning, monitoring, and execution across the lifecycle.

Conocimientos

Regulatory experience

Clinical trial management

GCP/ICH knowledge

Communication skills

Travel readiness

Educación

Bachelor's degree in life sciences

Descripción del empleo

Syneos Health is seeking a Clinical Trial Manager with Regulatory experience to oversee site qualification, initiation, monitoring and close-out activities in Mexico. The role ensures GCP/ICH compliance, manages data quality, and coordinates with sponsors across the trial lifecycle.

The candidate should have a bachelor’s degree in life sciences, strong regulatory knowledge, and excellent communication skills.