Global Clinical Operations Process Architect

Precisionmedicinegroup; México; Presencial; MXN 1.200.000 - 2.100.000; Jornada completa

Descripción de la vacante

Precision Medicine Group is seeking a Senior Manager, Clinical Operations – Clinical Process Owner to lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. The role owns SOPs, templates, and related documentation; interfaces with multiple functions and regions; and supports audits, CAPAs, and strategic initiatives.

The position requires senior-level expertise in clinical operations, strong cross-functional collaboration, and

Formación

• 5+ years of progressive clinical research or clinical operations experience in CRO/pharma/biotech/global outsourcing.
• Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness.

Responsabilidades

• Serve as the Clinical Process Owner for Clinical Operations processes, ensuring governance, accountability, lifecycle management, and alignment across regions/functions.
• Lead development, review, harmonization, implementation, and maintenance of SOPs, work instructions, tools, templates, and related documentation.
• Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity to establish clear, practical, scalable ways of working.
• Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, data, and stakeholder feedback into effective process solutions.
• Lead cross-functional process governance and decision-making with Clinical Operations, Quality Assurance, Regulatory, PM, Data Management, Biostatistics, Medical, Training, etc.
• Lead process implementation and change management, including impact assessment, stakeholder engagement, training, adoption monitoring, and evaluation of effectiveness.
• Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings; represent process capabilities to clients.

Conocimientos

Clinical Operations leadership

Cross-functional collaboration

Regulatory knowledge

Process improvement

Stakeholder management

Educación

Bachelor’s degree in life sciences/healthcare/clinical research

Descripción del empleo

Precision Medicine Group is seeking a Senior Manager, Clinical Operations – Clinical Process Owner to lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. The role owns SOPs, templates, and related documentation; interfaces with multiple functions and regions; and supports audits, CAPAs, and strategic initiatives.

The position requires senior-level expertise in clinical operations, strong cross-functional collaboration, and