Director

• Oversee and facilitate the personal development of the clinical data team (data managers and biostatisticians) including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings.
• Responsible for setting the strategic vision for the clinical data team to ensure high quality data and data analysis to support regulatory submissions.
• Strategic leadership, organizational, and operational management and guidance to the personnel and teams within the clinical data team.
• Lead the data team to ensure project timelines are met, with appropriate quality based on company priorities.
• Responsible for technical review of functional deliverables, including clinical study protocols, statistical analysis plans and reports, final study reports, and publications including abstracts and posters for the clinical data team.
• Partner with cross-functional leaders to optimize collaboration, resolve cross-functional operational challenges, and leverage resources efficiently.
• Champions the development, maintenance and implementation of processes and tools to ensure all external data follow data management plans, statistical analysis plans, applicable standards, study protocols, SOPs and overall clinical objectives.
• Lead the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards.
• Implement the corporate strategic plan within the clinical data team and collaborate with senior leadership with defining and managing the clinical data team budget, as required.
• Expertise in working with Electronic Data Capture (EDC) systems and clinical data management systems like Medrio.
• Responsible for staffing of the clinical data team for assigned projects.
• Maintain effective communication, coordination and working relations with other personnel and management, as well as director board, at the Quebec site.
• Must be able to concentrate, analyze and solve complex issues throughout the course of the work shift.

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