Clinical Operations Manager overseeing regulatory submissions, budgets, and country start - up for Parexel’s clinical development services. Bilingual French - English role with two weekly days at Merck’s Montreal/Kirkland office.
About the role
- Senior Manager optimizing CTMS and digital solutions for BeOne’s global clinical operations. Improving clinical trial efficiency, compliance, and technology value realization.
Responsibilities
- Enhance Global Clinical Operations productivity and reduce clinical trial inefficiencies
- Detail enhancements for CTMS and other digital solutions used across clinical trial planning, start-up, management, and close-out
- Engage clinical stakeholders across geographies and functions to define CTMS enhancement needs
- Elicit and align business, regional, and process requirements
- Prioritize demand, manage competing interests, communicate priorities, and translate them into development plans
- Draft and finalize business requirements for prioritized enhancements
- Coordinate with Development and IT teams on user stories, sprint planning, sprint testing, SDLC testing, and UAT
- Ensure digital applications align with GCO processes and create process flows where needed
- Support near-term and long-term CTMS and digital solution roadmaps
- Define value propositions and track business outcome measures for digital investments
- Represent GCO business interests on implementation teams
- Review proposed designs for fit, value, and business needs
- Curate the demand backlog and maintain user stories and priorities
- Manage the network of end-user champions and facilitate two-way communication
- Set up and maintain a SharePoint website for end-user and champion communications
- Analyze technology and industry trends to identify innovative, cost-effective solutions
- Implement the GCO technology roadmap
- Monitor, evaluate, optimize, troubleshoot, and resolve technology solution issues
- Manage project progress, timelines, accountabilities, risks, and costs
- Partner with Development Data Science, QA, IT, Clinical Operations, Data Management, and Supply Chain
- Develop solution requirements and standards
- Identify manual workflows and pain points and develop technological solutions
- Ensure business value realization and deliver change tactics including communications, training, user communities, and adoption drives
- Prioritize system usability, user satisfaction, and reduced user burden
- Work as an individual contributor and oversee consultants or analysts on a matrixed team as needed
Requirements
- Bachelor’s or master’s degree in computer science or related degree
- 7+ years’ experience in drug development clinical trial operations
- Clinical Operations domain expertise
- Business analysis on technology projects
- Knowledge of core clinical systems
- Knowledge of SDLC
- Experience with validated systems
- Requirement gathering and documentation
- Process modeling
- Familiarity with clinical operations applications such as CTMS
- Familiarity with data processing/engineering is a plus
- Ability to manage stakeholders and expectations
- Strong verbal and written communication skills
- Strong cross-cultural awareness
- Cross-functional collaboration skills
- Excellent conceptual, analytical, problem-solving, and troubleshooting skills
- Ability to drive forward progress
Benefits
- Equal opportunity employment
- Travel as needed
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