Senior Manager, Clinical Operations & Process Owner

Precision for Medicine; México; Presencial; MXN 1.200.000 - 1.800.000; 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 processes across the organization.

The role owns lifecycle management of SOPs, work instructions, tools, templates, and documentation, partnering with QA, Regulatory, PM, Data Management, Biostatistics, Medical,Training, and other functions to ensure compliant, scalable processes. This is a senior individual contributor role.

Formación

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field.
• 5+ years of progressive clinical research or clinical operations experience in CRO/pharma/biotech or global outsourcing.
• Proven experience leading complex cross-functional or global process improvement initiatives from assessment to implementation and evaluation.
• Strong knowledge of clinical trial operations, monitoring, site management and trial delivery processes.
• Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness.

Responsabilidades

• Serve as Clinical Process Owner for Clinical Operations processes with governance and lifecycle management across regions.
• Lead development, harmonization, implementation, and maintenance of SOPs, work instructions, tools, templates, and related documentation.
• Identify and resolve process gaps, duplication, inconsistencies, and unnecessary complexity to establish practical workflows.
• Translate regulatory requirements, ICH-GCP principles, quality standards, audits, CAPAs, and stakeholder feedback into process solutions.
• Lead cross-functional process governance and decision-making with multiple functions across regions.
• Lead process implementation and change management, including impact assessment, training, adoption monitoring, and evaluation of effectiveness.
• Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings; represent capabilities to clients.

Conocimientos

Cross-functional leadership

Process improvement

Regulatory knowledge

Influence stakeholders

Project management

Educación

Bachelor's degree in life sciences, healthcare, clinical research, business, or related field

Descripción del empleo

Precision Medicine Group is seeking a Senior Manager, Clinical Operations – Clinical Process Owner to lead governance, harmonization, and continuous improvement of processes across the organization.

The role owns lifecycle management of SOPs, work instructions, tools, templates, and documentation, partnering with QA, Regulatory, PM, Data Management, Biostatistics, Medical,Training, and other functions to ensure compliant, scalable processes. This is a senior individual contributor role.