Senior Manager, Clinical Operations

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

📋 Description

• Function as the Clinical Process Owner for Clinical Operations processes, ensuring efficient 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 resolve gaps in processes, duplication, 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 effective process solutions.

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

• Direct the implementation of processes and manage change, including impact assessments, stakeholder engagement, training and communication needs, monitoring of adoption, and evaluation of process effectiveness.

• Serve as a senior Clinical Operations Subject Matter Expert (SME) for strategic initiatives, audits, inspections, CAPAs, process evaluations, operational improvement efforts, and business development support, including proposals, budgets, contracts, and bid defense meetings.

⛳️ Requirements

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

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

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

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

• Strong knowledge 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 outcomes within a matrix organization.

• Documented experience in owning or leading the development, harmonization, 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 interconnections across functions.

• Capability to interpret regulatory and quality requirements and translate them into clear, proportionate, and practically operational processes.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Generous paid time off and holiday schedule.