Clinical System Lead

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical System Lead based in United States.** As a Clinical System Lead, you will provide technical and operational leadership across clinical trial data systems and Clinical Data Science projects. You will guide teams through the initiation, planning, configuration, maintenance, and closeout of clinical systems. The role combines clinical data expertise, project coordination, technical oversight, and client engagement. You will work closely with internal teams, external customers, vendors, and project leadership to deliver high-quality solutions. Your expertise will help ensure systems, timelines, resources, and deliverables remain aligned throughout each study. You will also contribute to business development activities, quality reviews, system integrations, and user acceptance testing. This is a remote opportunity with an international environment and approximately 15% domestic or international travel. ### Accountabilities - Lead and direct one or more Clinical Data Science project teams through the initiation, planning, setup, maintenance, control, and closure of clinical trial systems. - Support business development activities by providing technical expertise, contributing to proposals, and participating in or presenting at bid defense meetings. - Serve as a key contact for internal and external customer teams, ensuring effective communication and coordination throughout assigned studies. - Support and participate in internal and external project kickoff meetings and help establish clear expectations, timelines, and deliverables. - Conduct peer reviews and quality-control reviews of technical documentation, study team outputs, and clinical report forms (CRFs). - Monitor project issues that could affect timelines, scope, budgets, or deliverables, keeping functional and project management stakeholders informed and escalating risks when appropriate. - Work independently and collaboratively with project leads to negotiate timelines and key deliverables with clients, customers, and internal departments. - Contribute to the oversight and management of system integrations, including coordination with external vendors when required. - Lead or support internal user acceptance testing (UAT) for configured clinical system solutions and ensure issues are identified and addressed effectively. - Provide input to project-level revenue recognition and forecasting, including actual and forecasted hours, units, revenue, and resource requirements. - Travel approximately 15% domestically and/or internationally as required. ## Requirements - At least 2 years of clinical data management experience, including implementation and management of clinical data systems. - Strong technical understanding of relational databases and their underlying structures, with the ability to create medium- to complex-level data flow diagrams. - Practical project management skills, including the ability to anticipate timelines, resource requirements, deliverables, and financial considerations. - Detailed understanding of clinical trial protocols and data collection requirements, including both user experience considerations and underlying dataset structures. - Experience leading teams through internal user acceptance testing and supporting the implementation of configured clinical system solutions. - Excellent written and verbal communication skills, with the ability to work effectively with clients, technical teams, project managers, and other stakeholders. - Strong organizational and problem-solving capabilities, with the ability to identify risks, manage competing priorities, and maintain project momentum. - Adaptable and comfortable working in an agile environment where requirements, processes, and timelines can evolve quickly. - Ability to work independently while collaborating effectively with project leads and multidisciplinary teams. - Bachelor’s degree or local equivalent qualification. - Legal authorization to work in Canada is required. - Applications should be submitted in English. ## Benefits - Competitive base salary and performance-related incentives. - Health and wellbeing programs, including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programs and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Flexible remote working arrangements. - Opportunity to work in an international, collaborative clinical research environment. - Opportunities to contribute to projects that support the development and delivery of new medicines and medical devices. - Approximately 15% domestic and/or international travel, depending on project requirements. - Benefits may vary depending on role, location, and eligibility.