Senior Manager, Clinical Operations – Clinical Process Owner

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Act as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance, defined accountability, lifecycle management, and alignment across various regions and functions.

• Oversee the creation, review, standardization, implementation, and upkeep of Clinical Operations SOPs, work instructions, tools, templates, and associated documentation.

• Identify and address process gaps, redundancies, inconsistencies, conflicting requirements, and unnecessary complexities.

• Convert regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback into actionable process solutions.

• Lead and represent cross-functional process governance and decision-making involving Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other departments.

• Direct process implementation and change management, encompassing impact assessment, stakeholder engagement, training and communication needs, adoption monitoring, and evaluation of process effectiveness.

• Serve as a senior Clinical Operations Subject Matter Expert (SME) for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement efforts, and business development support.

• Provide Clinical Operations insights for proposals, budgets, contracts, and bid defense meetings.

• Showcase Clinical Operations process capabilities, delivery models, and operational strengths to potential clients.

• May lead cross-functional working groups, process teams, and strategic improvement initiatives.

⛳️ Requirements

• Bachelor's degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be taken into account.

• Minimum of 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment.

• Demonstrated experience leading complex cross-functional or global process improvement initiatives from assessment and design to implementation and effectiveness evaluation within a CRO setting.

• In-depth knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes.

• Strong understanding of ICH-GCP, regulatory expectations, quality standards, and principles of inspection readiness.

• Proven ability to influence stakeholders, facilitate decision-making, resolve conflicting requirements, and drive results in a matrix organization.

• Preferred: experience in owning or leading the development, standardization, implementation, and lifecycle management of Clinical Operations SOPs, work instructions, and related controlled documentation.

• Preferred: experience with process mapping, change management, Lean, or continuous improvement methodologies.

• Preferred: expert knowledge of Clinical Operations processes and their cross-functional interfaces.

• Preferred: capacity to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes.

🏝️ Benefits

• Remote work options available in the UK, Hungary, Poland, Romania, Serbia, or Slovakia.

• Regular full-time employment status.

• Commitment to equal opportunity employment.

• Reasonable accommodations provided during the application process for individuals with disabilities.