Senior Clinical Operations Process Owner

Precision For Medicine; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

Precision for Medicine seeks a Senior Manager, Clinical Operations – Clinical Process Owner to lead governance, harmonization, and ongoing improvement of processes across regions. You will own SOPs, work instructions, tools, templates, and related documentation, ensuring compliance, scalability, and practical application.

In this individual contributor leadership role, you will work cross-functionally with QA, Regulatory, PM, Data Management, Biostatistics, Medical, Training, and other teams,

Qualifications

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field.
• At least 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment.
• Proven experience leading complex cross-functional or global process improvement initiatives from assessment and design through implementation and effectiveness evaluation within a CRO environment.
• Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes.
• Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles.
• Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization.
• Demonstrated experience owning or leading the development, harmonization, implementation, and lifecycle management of SOPs, work instructions, and related documentation.
• Experience with process mapping, change management, Lean, or continuous improvement methodologies.
• Expert understanding of Clinical Operations processes and their cross-functional interfaces.
• Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes.

Responsibilities

• Serve as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance, clear accountability, lifecycle management, and alignment across regions and functions.
• Lead the development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs, work instructions, tools, templates, and related documentation.
• Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity to establish clear, practical, and scalable ways of working.
• Translate regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback into effective process solutions.
• Lead and represent cross-functional process governance and decision-making, partnering with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other relevant functions.
• Lead process implementation and change management, including impact assessment, stakeholder engagement, training and communication requirements, adoption monitoring, and evaluation of process effectiveness.
• Act as a senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support.

Skills

ICH-GCP knowledge

Cross-functional collaboration

Process improvement

Regulatory compliance

Education

Bachelor’s degree in life sciences or related field

Job description

Precision for Medicine seeks a Senior Manager, Clinical Operations – Clinical Process Owner to lead governance, harmonization, and ongoing improvement of processes across regions. You will own SOPs, work instructions, tools, templates, and related documentation, ensuring compliance, scalability, and practical application.

In this individual contributor leadership role, you will work cross-functionally with QA, Regulatory, PM, Data Management, Biostatistics, Medical, Training, and other teams,