Senior Manager, Clinical Operations

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

📋 Description

• Act as the Clinical Process Owner for Clinical Operations processes, ensuring robust governance, clear 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 mandates, ICH-GCP principles, quality benchmarks, audit and inspection outcomes, CAPAs, operational data, and stakeholder insights into actionable process solutions.

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

• Spearhead process implementation and change management, which includes impact assessment, stakeholder involvement, training and communication strategies, adoption tracking, and effectiveness evaluation.

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

• Contribute Clinical Operations insights for proposals, budgets, contracts, and bid defense meetings, showcasing process capabilities, delivery models, and operational strengths to potential clients.

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

⛳️ Requirements

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

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

• Proven track record of leading intricate cross-functional or global process improvement initiatives from assessment and design through to implementation and effectiveness evaluation.

• 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.

• Demonstrated capability to influence stakeholders, facilitate decision-making, resolve conflicting requirements, and drive outcomes within a matrix organization.

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

• Familiarity with process mapping, change management, Lean, or continuous improvement methodologies.

• Expert understanding of Clinical Operations processes and their interrelationships across functions.

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance plans.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• A collaborative and inclusive work environment.