This is an exciting opportunity to drive digital transformation and operational excellence within global clinical research. As Senior Manager, Digital Clinical Operations, you will help optimize clinical trial processes by enhancing clinical technology platforms, particularly Clinical Trial Management Systems (CTMS), and other digital solutions. You will serve as a strategic link between clinical stakeholders, IT, Development, and cross-functional teams to translate business needs into effective technology solutions. Your work will focus on improving efficiency, reducing clinical trial costs, and enabling reliable, data-driven decision-making throughout the clinical trial lifecycle. You will shape digital roadmaps, prioritize enhancements, and ensure that technology investments deliver measurable business value. This role offers the opportunity to introduce innovative approaches, streamline workflows, and improve the experience of clinical teams across global markets. Join a collaborative, science-driven environment committed to advancing clinical development and improving patient access to innovative treatments.
- 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.
Benefits
- 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.
