Senior Manager, Clinical Operations – Clinical Process Owner

About the role

The Senior Manager, Clinical Operations – Clinical Process Owner leads governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. The role owns development, simplification, alignment, and lifecycle management of SOPs, work instructions, tools, templates, and related documentation. It works cross‑functionally and across regions to ensure processes are compliant, practical, scalable, and consistently applied.

Key responsibilities

• Serve as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance, clear accountability, and lifecycle management across regions and functions.
• Lead development, review, harmonization, implementation and maintenance of Clinical Operations SOPs, work instructions, tools, templates and related documentation.
• Identify and resolve process gaps, duplication, inconsistencies and unnecessary complexity to create clear, scalable ways of working.
• Translate regulatory requirements, ICH‑GCP principles, audit findings, CAPAs and stakeholder feedback into effective process solutions.
• Represent cross‑functional process governance, partnering with Clinical Operations, QA, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training and other functions.
• Lead process implementation and change management, including impact assessment, stakeholder engagement, training, communication and adoption monitoring.
• Act as senior Clinical Operations SME for audits, inspections, CAPAs, strategic initiatives and business development activities, providing input for proposals, budgets and bid defenses.

Required profile

• Bachelor’s degree in life sciences, healthcare, clinical research, business or a related field (or equivalent experience).
• Minimum 5 + years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology or global clinical outsourcing environment.
• Proven experience in process governance, SOP lifecycle management and cross‑functional collaboration.
• Strong understanding of ICH‑GCP, regulatory requirements, quality standards and audit/inspection processes.

Required skills

• Process governance and continuous improvement.
• SOP development, harmonization and lifecycle management.
• Change management and stakeholder engagement.
• Regulatory and quality compliance (ICH‑GCP, CAPA).