Senior Manager optimizing CTMS and digital solutions for BeOne’s global clinical operations. Improving clinical trial efficiency, compliance, and technology value realization.
About the role
- Senior Clinical Operations Manager leading clinical operations, monitoring, and trial quality at Indero, a dermatology and rheumatology CRO. Overseeing teams, resources, compliance, budgets, and AI-enabled process improvement across North America.
Responsibilities
- Provide line management and performance oversight for Clinical Operations personnel, including CRAs, CTMs, and other Clinical Operations roles
- Ensure clinical monitoring and trial management activities meet sponsor expectations, quality standards, timelines, budgets, SOPs, regulations, good clinical practices, and study-specific requirements
- Support hiring, onboarding, training, development, retention, and succession planning
- Provide coaching and mentorship
- Assist in developing, delivering, and overseeing training programs
- Ensure consistent adoption of SOPs, tools, and systems
- Oversee resource planning and allocation across studies
- Track Clinical Operations metrics, performance trends, targets, and capacity planning
- Monitor study budget utilization and financial performance
- Partner with Project Management and Finance to identify risks and implement mitigation strategies
- Perform or oversee Quality Assessment Visits and site visit report reviews
- Identify risks and quality issues and ensure corrective and preventive actions
- Serve as an escalation point for Clinical Operations teams, sponsors, and stakeholders
- Drive innovation and continuous improvement, including adoption of technology, automation, and AI-enabled solutions
- May be assigned other responsibilities when qualified and/or adequately trained
Requirements
- Bachelor’s Degree in a field relevant to clinical research
- Minimum 10 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry
- Experience including monitoring and senior operational oversight as a Clinical Operations Manager, Project Manager, Clinical Trial Manager, or equivalent job role
- Good experience in the field of monitoring
- Experience in a CRO is an asset
- Excellent oral and written English skills
- Excellent mastery of Microsoft Office suite (Word, Excel, Power Point)
- Ability to work in a fast-paced evolving environment and establish good relationships with colleagues and sponsors
- Ability to liaise successfully with clinical project teams and other departments
- Quick learner, good adaptability and versatile
- Demonstrated interest and proficiency in innovation, digital transformation, and operational process optimization within clinical research
- Comfortable using AI-powered tools and productivity platforms (e.g., ChatGPT, Microsoft Copilot, Gemini, or similar technologies)
- Comfortable adapting to new technologies, systems, and industry practices
- Proven ability to lead change management initiatives and influence cross-functional teams
- Excellent leadership, judgement, and problem-solving skills
- Strong organizational, communication, time management and multi-tasking skills
- Willingness to travel up to 20% of the time
- Good knowledge of good clinical practices
- Knowledge of applicable Health Canada, Food and Drug Administration (FDA), European Medicines Agency (EMA) regulations/guidelines and other applicable regulatory requirements
- Must be legally able to work in Canada or the United States
Benefits
- Permanent full-time position
- Vacation
- Benefits
- Health allowance
- RRSP or 401K
- Yearly bonus structure %
- Home-based position with teleworking allowance
- Ongoing learning and development
- Equitable treatment and equal opportunity
- Accommodations throughout the recruitment and selection process to applicants with disabilities, upon request
Job title
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