Senior Clinical Operations Manager

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🔥 0 minutes ago

🌐 Canada, United States – Remote

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⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 12%

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Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• 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

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