Senior Manager, Clinical Operations

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

📋 Description

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

• Drive the development, review, harmonization, implementation, and upkeep of Clinical Operations Standard Operating Procedures (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 across Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other relevant functions.

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

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

• Provide input from Clinical Operations for proposals, budgets, contracts, and bid defense meetings, while showcasing process capabilities and delivery models to prospective clients.

• Lead cross-functional working groups, process teams, and strategic improvement initiatives as required.

⛳️ Requirements

• A Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field; equivalent professional 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 environment.

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

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

• In-depth 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.

• Demonstrated experience in owning or steering 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 knowledge of Clinical Operations processes and their interconnections across functions.

• Capability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally 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