In this role you support clinical trial activities and documentation to enable efficient study execution. You will work with cross-functional teams to manage trial records, site activation, and regulatory submissions, ensuring quality and timely delivery. You help maintain eTMF and ISFs, support risk-driven monitoring, and facilitate communications across sites. This position offers exposure to international trials and a path to grow in clinical research within a collaborative environment.
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Collaborative and inclusive environment
Hands-on experience across site activation, regulatory documentation, and study management
Continuous learning and professional development
Career progression opportunities
Competitive compensation and benefits
Coordinate and complete assigned clinical trial activities per the study task matrix
Review country and investigator files; document findings in systems
Support audit readiness by ensuring study files follow schedules and procedures
Process and maintain documentation within the eTMF; resolve missing or incomplete items
Assist with ISFs, pharmacy binders, and study supplies preparation
Support translations and translation quality control as required
Provide administrative support for site activation and start-up activities
Track regulatory documentation and assist with regulatory submissions
Maintain records of site communications, follow-ups, and survey responses
Support RBM activities and study coordination across platforms (Activate, eTMF, etc)
Assist with scheduling internal/client meetings and distributing project communications
Collaborate with cross-functional teams to meet milestones and deadlines
Communicate xysqume site-related issues and risks to clinical and project colleagues
High school/secondary diploma or equivalent
Additional university-level education in life sciences or healthcare is an advantage
Experience is beneficial but candidates with the right knowledge and motivation may be considered
Equivalent combinations of education, training, and directly related experience may be considered
In this role you support clinical trial activities and documentation to enable efficient study execution. You will work with cross-functiona…
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