Senior Manager, Digital Clinical Operations
Your tasks
- Lead the identification, analysis, and prioritization of enhancements to CTMS and other digital applications supporting clinical trial planning, study startup, execution, and closeout.
- Engage with clinical stakeholders across regions and functions to gather business requirements, understand operational challenges, and establish a clear, unified vision for digital improvements.
- Translate business needs into detailed functional requirements, user stories, process maps, and acceptance criteria in collaboration with Development and IT teams.
- Facilitate demand prioritization by evaluating business value, organizational objectives, implementation effort, and competing stakeholder needs while maintaining transparent communication about decisions and timelines.
- Contribute to short- and long-term digital roadmaps, ensuring technology solutions align with clinical operations processes, regulatory requirements, and strategic priorities.
- Participate in solution design reviews, sprint planning, software development lifecycle activities, system testing, and user acceptance testing to ensure solutions meet business expectations.
- Identify opportunities to standardize, optimize, and automate workflows, developing process documentation and operating models where existing processes are unclear or inefficient.
- Monitor the performance, usability, quality, and compliance of clinical technology solutions, helping troubleshoot issues and identify opportunities for continuous improvement.
- Define and track measurable business outcomes for digital investments, including productivity gains, cost efficiencies, reduced manual effort, and improved clinical trial execution.
- Represent clinical operations stakeholders throughout technology implementation projects, ensuring business requirements and user needs remain central to solution delivery.
- Maintain and prioritize the product backlog, keeping user stories, requirements, dependencies, and delivery priorities accurate and up to date.
- Build and maintain effective communication channels with end users and stakeholder champions, including dedicated SharePoint resources, training materials, and adoption initiatives.
- Coordinate change management activities, including communications, training, user engagement, and adoption programs for new or enhanced systems.
- Collaborate with Quality Assurance, Data Science, IT, Data Management, Supply Chain, and other relevant teams to support system documentation, lifecycle management, validated systems, and the implementation of new technologies.
- Manage project progress, timelines, risks, costs, and stakeholder expectations, while promoting a culture of agility, compliance, innovation, and data-driven decision-making.
- Evaluate emerging technologies and industry trends to identify practical opportunities to improve clinical operations and support the evolution of digital capabilities.
- Work as an individual contributor while providing guidance or oversight to consultants and analysts within matrixed teams when needed.
Requirements
- Bachelor's or master's degree in Computer Science or a related discipline.
- At least 7 years of experience in drug development and clinical trial operations, with strong expertise in clinical operations processes and their associated technology needs.
- Demonstrated experience in business analysis for technology projects, including requirements gathering, documentation, process modeling, and translating business needs into functional solutions.
- Familiarity with core clinical systems, particularly Clinical Trial Management Systems (CTMS), and an understanding of their role across the clinical trial lifecycle.
- Knowledge of the software development lifecycle (SDLC), system testing, user acceptance testing, and validated systems in regulated environments.
- Experience collaborating with technical teams, business stakeholders, and external partners to deliver technology enhancements aligned with operational objectives.
- Strong analytical, conceptual, and problem-solving skills, including the ability to identify process inefficiencies, investigate system issues, interpret data, and recommend practical solutions.
- Excellent project coordination and organizational skills, with the ability to manage competing priorities, monitor progress, and drive initiatives forward.
- Strong stakeholder management capabilities, including experience aligning functional leaders, communicating trade-offs, and managing expectations across geographically distributed teams.
- Excellent written and verbal communication skills, with the ability to explain complex technical concepts and business insights to non-technical audiences.
- Cross-cultural awareness and a collaborative approach to working with global, multidisciplinary teams.
- A proactive, adaptable, and results-oriented mindset, with the ability to embrace change, demonstrate initiative, and balance strategic thinking with hands-on execution.
- Commitment to continuous improvement, compliance, data-driven decision-making, and thoughtful adoption of technology.
- Familiarity with data processing or data engineering is considered an advantage.
- Willingness to travel as needed.
What we offer
- Competitive compensation: Annual salary ranging from CAD $140,900 to $176,100.
- Remote work: Canada-based remote working arrangement.
- Meaningful impact: Opportunity to improve clinical trial efficiency and support the development of innovative treatments for patients worldwide.
- Global collaboration: Work with multidisciplinary teams and stakeholders across international markets and functions.
- Professional growth: Exposure to digital transformation, clinical technology strategy, process optimization, and emerging industry innovations.
- Strategic influence: Contribute to technology roadmaps, business prioritization, and measurable operational improvements.
- Inclusive workplace: Join a collaborative environment that values teamwork, initiative, continuous learning, and diverse perspectives.
- Innovation-driven culture: Help introduce new technologies and improve how clinical operations teams work.
- Travel opportunities: Occasional travel as required to support stakeholder collaboration and business initiatives.
Other
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