Senior Manager, Clinical Operations

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

📋 Description

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

• Spearhead the development, review, harmonization, implementation, and maintenance 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 effective process solutions.

• Lead 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.

• Oversee process implementation and change management, which includes impact assessment, stakeholder engagement, training, communication, adoption monitoring, and effectiveness evaluation.

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

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

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

• Potentially 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 will 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.

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

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

• Solid knowledge 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.

• Preferred: experience in owning or managing Clinical Operations SOPs, work instructions, and controlled documentation.

• Preferred: expertise in process mapping, change management, Lean, or continuous improvement methodologies.

• Preferred: in-depth understanding of Clinical Operations processes and cross-functional interfaces.

• Preferred: ability to interpret regulatory and quality requirements and translate them into practical processes.

🏝️ Benefits

• Discretionary annual bonus

• Health insurance

• Retirement savings benefits

• Life insurance

• Disability benefits

• Parental leave

• Paid time off for sick leave and vacation