Senior Clinical Operations Manager, Canada/USA, remote

Indero•English, IN

1d•Remote

About The Position

The Senior Clinical Operations Manager (Sr. COM) provides line management and performance oversight for Clinical Operations personnel, including Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and other Clinical Operations roles. The role ensures high-quality, compliant, and efficient clinical monitoring and trial management services, and provides strategic oversight, coaching, escalation support, and quality governance. The Sr. COM is also accountable for driving innovation, continuous improvement, and adoption of technology, automation, and AI-enabled solutions. The position oversees assigned teams’ monitoring and trial management activities to ensure sponsor satisfaction, timely and high-quality deliverables, budget adherence, and compliance with SOPs, regulations, good clinical practices, and study requirements. It includes personnel development, hiring and onboarding support, training oversight, resource planning, performance metrics, budget utilization monitoring, risk mitigation, quality assessment visits, site visit report reviews, and corrective and preventive actions. The Sr. COM serves as an escalation point for Clinical Operations teams, sponsors, and stakeholders, and partners with Project Management and Finance. This is a permanent, full-time, home-based position open to candidates across Canada or the United States. Travel may be required up to 20% of the time. Indero is a dermatology- and rheumatology-specialized CRO based in Montreal that has operated since 2000 and is expanding in North America and Europe.

Requirements

Bachelor’s degree in a field relevant to clinical research.
At least 10 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry, including monitoring and senior operational oversight as a Clinical Operations Manager, Project Manager, Clinical Trial Manager, or equivalent.
Good experience in clinical monitoring.
Excellent oral and written English skills.
Excellent command of Microsoft Office, including Word, Excel, and PowerPoint.
Ability to work in a fast-paced, evolving environment and build good relationships with colleagues and sponsors.
Ability to work successfully with clinical project teams and other departments.
Quick learning, adaptability, and versatility.
Demonstrated interest and proficiency in innovation, digital transformation, and operational process optimization in clinical research.
Comfort using AI-powered tools and productivity platforms such as ChatGPT, Microsoft Copilot, Gemini, or similar tools to support daily work and improve efficiency.
Comfort adapting to evolving environments, technologies, systems, and industry practices.
Proven ability to lead change-management initiatives and influence cross-functional teams.
Excellent leadership, judgment, and problem-solving skills.
Strong organizational, communication, time-management, and multitasking skills.
Willingness to travel up to 20% of the time.
Good knowledge of good clinical practices and applicable Health Canada, FDA, EMA, and other regulatory requirements.

Nice To Haves

Experience in a CRO is an asset.

Responsibilities

Ensure assigned teams’ clinical monitoring and trial management activities meet sponsor expectations and deliver high-quality work on time, within budget, and in compliance with SOPs, regulations, good clinical practices, and study requirements.
Provide line management and performance oversight for CRAs, CTMs, and other Clinical Operations personnel, aligning performance objectives with departmental goals, study requirements, and company strategy and taking remedial action when needed.
Support hiring, onboarding, training, development, retention, and succession planning, including coaching and mentorship.
Assist in developing, delivering, and overseeing training programs and promote consistent adoption of SOPs, tools, and systems.
Oversee resource planning and allocation across studies to ensure appropriate staffing and balanced workloads.
Track Clinical Operations metrics, monitor performance trends and target adherence, and support capacity planning.
Ensure Clinical Operations work is performed within approved study budgets and monitor utilization and financial performance.
Partner with Project Management and Finance to identify risks and implement mitigation strategies.
Perform or oversee Quality Assessment Visits (QAVs) and review site visit reports.
Identify risks and quality issues and ensure corrective and preventive actions are implemented.
Act as an escalation point for Clinical Operations teams, sponsors, and stakeholders.
Drive innovation and continuous improvement, including adoption of technology and AI-enabled solutions.