Senior Manager, Clinical Operations - Clinical Process Owner

As Senior Manager, Clinical Operations, you will lead governance and continuous improvement of clinical operations processes across regions. You’ll own the lifecycle of SOPs, work instructions, and templates, ensuring compliant, scalable practices. You’ll partner across functions to drive change, support audits and CAPAs, and contribute to strategic initiatives and business development. This role offers cross-regional influence and a path to shape operational Excellence in precision medicine.

• Serve as Clinical Process Owner for Clinical Operations processes with governance and lifecycle management
• Develop, review, harmonize, implement, and maintain SOPs, work instructions, tools, and templates
• Identify gaps, duplication, inconsistencies, and unnecessary complexity to enable clear, scalable ways of working
• Translate regulatory requirements, ICH-GCP, quality standards, audit findings, CAPAs, and stakeholder feedback into process solutions
• Lead cross-functional governance and decision-making with Clinical Operations, QA, Regulatory, PM, Data Management, Biostatistics, Medical, Training, and others
• Lead process implementation and change management including impact assessment, stakeholder engagement, training, adoption monitoring, and evaluation
• Provide Clinical Operations input for strategic initiatives, audits, inspections, CAPAs, process assessments, and business development, including proposals and budgets

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field; equivalent experience considered
• 5+ years of progressive clinical research or clinical operations experience in CRO/pharma/global outsourcing
• Proven experience leading complex cross-functional or global process improvement initiatives in a CRO environment
• Strong knowledge of clinical trial operations, monitoring, site management, and cross-functional trial delivery
• Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness
• Demonstrated ability to influence stakeholders and drive outcomes in a matrix organization

• Influence and stakeholder management
• Cross-functional collaboration
• Change management and training
• SOPs lifecycle management
• Process mapping and documentation
• Change management methodologies (e.g., Lean)