Senior Manager, Clinical Operations

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

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

• Guide the creation, assessment, harmonization, execution, and upkeep of Clinical Operations SOPs, work instructions, tools, templates, and associated documentation.

• Recognize and address process gaps, redundancies, inconsistencies, conflicting needs, and unnecessary complexities to create clear, practical, and scalable workflows.

• Convert regulatory mandates, ICH-GCP standards, quality benchmarks, audit and inspection outcomes, CAPAs, operational data, and stakeholder insights into effective process solutions.

• Lead and represent cross-functional process governance and decision-making in collaboration with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other pertinent functions.

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

• Serve as a senior Clinical Operations Subject Matter Expert for strategic initiatives, audits, inspections, CAPAs, process evaluations, operational improvement efforts, and business development support, which includes offering Clinical Operations insights for proposals, budgets, contracts, and bid defense meetings, as well as showcasing Clinical Operations process capabilities to potential clients.

⛳️ Requirements

• A bachelor’s degree in life sciences, healthcare, clinical research, business, or a related area; equivalent experience may be considered.

• Over 5 years of progressive experience in clinical research or clinical operations within a CRO, pharmaceutical, biotechnology, or global clinical outsourcing setting.

• Demonstrated experience leading complex cross-functional or global process improvement projects from assessment and design to implementation and evaluation of effectiveness.

• Solid understanding of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes.

• Strong familiarity with ICH-GCP, regulatory requirements, quality standards, and principles of inspection readiness.

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

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Supportive and inclusive company culture.