Senior Manager, Clinical Operations & Process Excellence

Pfm; México; Presencial; MXN 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

Precision Medicine Group seeks a Senior Manager, Clinical Operations – Clinical Process Owner to drive governance, harmonization, and continuous improvement of Clinical Operations processes. You will own the development and lifecycle management of SOPs, work instructions, tools, templates, and related documents.

working cross-region, ensuring compliant, scalable, and consistently applied processes, and supporting audits, CAPAs, and strategic initiatives.

Formación

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field.
• 5+ years in clinical research or clinical operations in CRO/pharma/global setting.
• Experience leading cross-functional process improvement initiatives.
• Knowledge of clinical trial operations, monitoring, site management, and cross-functional delivery.
• Knowledge of ICH-GCP, regulatory expectations, quality standards.
• Ability to influence stakeholders in a matrix organization.

Responsabilidades

• Lead governance for Clinical Operations processes and lifecycle management of SOPs, work instructions, tools, templates, and related documentation.
• Identify and resolve process gaps, duplication, and complexity to establish practical, scalable processes.
• Translate regulatory requirements and quality standards into effective process solutions.
• Lead cross-functional process governance and decision-making with multiple functions across regions.
• Oversee process implementation, change management, and stakeholder training; monitor adoption and effectiveness.
• Support audits, inspections, CAPAs, and business development activities as needed.

Conocimientos

Process governance

Cross-functional leadership

Regulatory knowledge

ICH-GCP knowledge

Stakeholder influence

Audit support

Educación

Bachelor's degree in life sciences / healthcare / clinical research / business

Descripción del empleo

Precision Medicine Group seeks a Senior Manager, Clinical Operations – Clinical Process Owner to drive governance, harmonization, and continuous improvement of Clinical Operations processes. You will own the development and lifecycle management of SOPs, work instructions, tools, templates, and related documents.

working cross-region, ensuring compliant, scalable, and consistently applied processes, and supporting audits, CAPAs, and strategic initiatives.