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 robust governance, defined accountability, lifecycle management, and alignment across various regions and functions.

• Spearhead the creation, review, harmonization, 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 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 departments.

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

• Serve as a senior Clinical Operations Subject Matter Expert for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support, such as proposals, budgets, contracts, bid defense meetings, and client presentations.

⛳️ Requirements

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

• Over 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 intricate cross-functional or global process improvement initiatives, from assessment and design through implementation and evaluation of effectiveness.

• 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.

• Proven ability to influence stakeholders, facilitate decision-making, resolve conflicting requirements, and drive results within a matrixed organization.

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

• Expert knowledge of Clinical Operations processes and their interconnections across functions.

• Ability to interpret regulatory and quality requirements and convert them into clear, proportional, and operationally feasible processes.

🏝️ Benefits

• Discretionary annual bonus

• Health insurance

• Retirement savings benefits

• Life insurance

• Disability benefits

• Parental leave

• Paid time off for sick leave and vacation