Manager, Clinical Data and Safety Monitoring

Accountabilities:

• Lead day-to-day clinical data and safety monitoring activities within the DMC/DSMB administration function, overseeing project planning, execution, tracking, and delivery while ensuring established policies, procedures, quality standards, and timelines are followed.
• Mentor project team members, monitor adherence to established standards, and support the recruitment, training, motivation, performance management, and professional development of staff.
• Manage DMC/DSMB administration projects, including identifying and engaging committee members, coordinating agreements and honorarium payments, serving as a liaison with sponsors, and supporting effective committee operations.
• Develop or coordinate DMC/DSMB Charters and amendments, organize committee reviews and approvals, and coordinate the preparation and distribution of data reports and related deliverables.
• Plan and coordinate committee meetings, prepare project timelines, support meeting documentation, produce minutes when serving as Secretary, and assist with recommendation letters and follow-up actions.
• Coordinate activities among sponsors, internal teams, external vendors, statistical programming groups, and committee members, ensuring clear communication of project assumptions, decisions, responsibilities, and action items.
• Monitor project budgets, hours, invoices, timelines, milestones, and deliverables, and prepare accurate status and progress reports for relevant stakeholders.
• Facilitate problem solving and conflict resolution, working with functional leaders to support effective decisions and strategic plans for DMC/DSMB administration projects.
• Establish and achieve departmental goals, monitor KPIs and performance metrics, and analyze results to identify opportunities for operational improvement.
• Contribute to the development and maintenance of policies, SOPs, working instructions, guidelines, and best practices related to DMC/DSMB administration.
• Support the evaluation and implementation of new reporting systems, tools, and processes designed to improve service effectiveness and quality.
• Build strong client relationships by maintaining a customer-focused approach and consistently delivering high-quality work.
• Support business development activities, including cost estimates, proposal responses, and bid defense preparation and participation.
• Conduct business analysis and benchmarking, identify opportunities for continuous improvement, and represent departmental needs as part of the management team.
• Maintain current knowledge of applicable DMC/DSMB regulations and requirements while ensuring compliance with relevant guidance and professional standards.

Requirements:

• Advanced degree, preferably a Ph.D., in Clinical Sciences, Medical Sciences, Life Sciences, or a related discipline; a master’s degree combined with substantial relevant experience may also be considered.
• At least 8 years of clinical trial experience within an academic, pharmaceutical, or CRO environment, including at least 5 years of experience administering DMCs/DSMBs.
• At least 3 years of experience managing people and/or clinical research projects.
• Strong knowledge of DMC/DSMB regulations and industry standards, with demonstrated understanding and practical experience applying GCP and ICH guidelines.
• Strong understanding of clinical trials and common clinical trial statistical analysis methods, with the ability to interpret medical information and clinical results effectively.
• Experience across multiple therapeutic areas and Phase I through Phase IV clinical trials is considered an asset.
• Excellent written and verbal communication skills, with the ability to communicate complex clinical and medical information clearly to diverse stakeholders.
• Strong organizational and project management abilities, including the capacity to manage multiple projects, clients, priorities, and changing requirements simultaneously.
• Excellent interpersonal and teamwork skills, combined with a detail-oriented, quality-focused, and customer-focused approach.
• Demonstrated flexibility, adaptability, independent judgment, and sound decision-making when working both independently and as part of a team.
• Ability to maintain a high level of confidentiality when handling clinical data and proprietary client information.
• Strong proficiency with Microsoft Office and Adobe Acrobat; experience with the TRS Toolbox Pharma Edition plugin is considered an asset.

Benefits:

• Estimated annual salary range of $120,000–$140,000.
• Medical, dental, and vision coverage.
• Life and AD&D insurance.
• Short-term and long-term disability coverage.
• Tuition reimbursement to support continued professional development.
• Fitness reimbursement.
• Employee Assistance Program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.
• Opportunity to work on clinical research programs involving DMC/DSMB administration, clinical data, safety monitoring, and multiple therapeutic areas.
• Leadership and professional development opportunities through team management, client engagement, business development, and departmental initiatives.
• Flexible work arrangement, with the position available on-site in Toronto/Markham or remotely from a home-based office anywhere in Canada, in accordance with the applicable work-from-home policy.
• An inclusive environment committed to dignity, independence, integration, equal opportunity, and accessibility, with accommodations available throughout the recruitment and selection process.