Senior Manager, Clinical Operations - Clinical Process Owner

About the role

The Senior Manager, Clinical Operations – Clinical Process Owner leads governance, harmonisation and continuous improvement of Clinical Operations processes across the organisation. This individual contributor role influences functions, regions and senior leaders while ensuring processes are compliant, practical and scalable.

Key responsibilities

• Own the Clinical Operations process portfolio, providing governance, clear accountability and lifecycle management.
• Develop, review, harmonise and maintain SOPs, work instructions, tools, templates and related documentation.
• Identify and resolve process gaps, duplication and unnecessary complexity to create scalable ways of working.
• Translate regulatory requirements, ICH‑GCP principles, audit findings and stakeholder feedback into effective process solutions.
• Lead cross‑functional process governance, partnering with Quality, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training and other functions.
• Manage process implementation and change, 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 support.

Required profile

• Bachelor’s degree in life sciences, healthcare, clinical research, business or a related field (or equivalent experience).
• Minimum 5 + years progressive experience in clinical research or clinical operations within a CRO, pharmaceutical, biotechnology or global clinical outsourcing environment.
• Proven experience in process governance, SOP development and cross‑functional collaboration.

Required skills