Senior Clinical Operations Manager

Accountabilities

• Clinical operations leadership: Oversee clinical monitoring and trial management activities across assigned teams, ensuring high-quality deliverables, sponsor satisfaction, and compliance with timelines, budgets, standard operating procedures, Good Clinical Practice (GCP), and study-specific requirements.

• Team management and development: Lead, coach, and evaluate Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and other clinical operations professionals. Support recruitment, onboarding, training, retention, succession planning, and professional development while ensuring individual performance aligns with departmental objectives.

• Resource and capacity planning: Coordinate staffing and resource allocation across studies, maintain balanced workloads, anticipate capacity requirements, and ensure teams have the expertise and support needed to deliver clinical projects effectively.

• Performance and financial oversight: Monitor operational KPIs, performance trends, productivity, and resource utilization. Ensure study activities remain within approved budgets and collaborate with Project Management and Finance to identify financial or operational risks and implement mitigation strategies.

• Quality assurance and compliance: Conduct or oversee Quality Assessment Visits (QAVs), review site visit reports, identify quality concerns, and ensure appropriate corrective and preventive actions are implemented. Promote consistent adherence to regulatory requirements, internal procedures, and quality standards.

• Risk management and escalation: Act as a key escalation point for clinical operations teams, sponsors, and stakeholders. Address complex operational challenges, support proactive problem-solving, and ensure timely resolution of issues affecting study quality or delivery.

• Training and process improvement: Contribute to the development and implementation of training programs, ensuring consistent adoption of clinical operations procedures, tools, and systems. Identify opportunities to streamline workflows and improve operational effectiveness.

• Innovation and digital transformation: Champion continuous improvement through technology, automation, and AI-enabled solutions. Explore practical applications of digital tools to increase CTM productivity, strengthen oversight, improve decision-making, and enhance clinical trial delivery.

• Cross-functional collaboration: Build strong working relationships with clinical project teams and other departments to align priorities, share expertise, manage change, and support the organization's broader operational objectives.

Requirements

• Education: Bachelor's degree in clinical research or a related field.

• Professional experience: At least 10 years of clinical research experience within the biotechnology, pharmaceutical, or contract research organization (CRO) industry, including clinical monitoring and senior operational oversight as a Clinical Operations Manager, Project Manager, Clinical Trial Manager, or in an equivalent position.

• Clinical monitoring expertise: Strong practical experience in clinical monitoring, with a solid understanding of study management, site oversight, quality assurance, and clinical trial delivery. Previous experience working within a CRO is an asset.

• Regulatory knowledge: Good understanding of Good Clinical Practice (GCP) and applicable regulations and guidelines from Health Canada, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other relevant regulatory authorities.

• Leadership and people development: Demonstrated ability to manage, coach, and develop clinical operations professionals, establish clear performance expectations, and foster a collaborative, accountable, and high-performing team culture.

• Digital and technical proficiency: Excellent command of Microsoft Office applications, including Word, Excel, and PowerPoint. Demonstrated interest in innovation, digital transformation, and process optimization, with the ability to use AI-powered tools such as ChatGPT, Microsoft Copilot, Gemini, or similar platforms to improve daily workflows and productivity.

• Operational and analytical skills: Strong organizational, planning, time-management, and multitasking abilities, with sound judgment, problem-solving skills, and the capacity to monitor performance metrics and manage competing priorities.

• Communication and relationship management: Excellent written and spoken English, with the ability to communicate effectively with sponsors, clinical project teams, colleagues, and cross-functional stakeholders. Strong interpersonal skills and the ability to build productive professional relationships are essential.

• Adaptability and change management: Ability to thrive in a fast-paced, evolving environment, learn new systems quickly, adapt to changing industry practices, and lead improvement initiatives across teams.

• Availability: Willingness to travel up to 20% of the time. Candidates must be legally authorized to work in Canada.

Benefits

• Employment stability: Permanent, full-time position.

• Remote flexibility: Home-based role open to candidates across United States, with a teleworking allowance.

• Health and wellness: Benefits package and health allowance.

• Retirement savings: Access to an RRSP or 401(k) retirement savings plan, depending on eligibility and location.

• Performance incentives: Annual bonus structure.

• Time off: Vacation allowance to support work-life balance.

• Professional development: Ongoing learning opportunities, training, and career development support.

• Collaborative environment: Work alongside experienced clinical research professionals in a culture that values collaboration, innovation, reliability, and responsiveness.

• Meaningful impact: Help improve clinical trial quality, strengthen patient safety, and advance research in dermatology and rheumatology.

• Inclusive workplace: Commitment to equitable employment opportunities and reasonable accommodations throughout the recruitment and selection process.