Manager, Clinical Data and Safety Monitoring in Canada at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Clinical Data and Safety Monitoring based in Canada.

This leadership role oversees clinical data and safety monitoring activities supporting DMC/DSMB administration across clinical research programs. It combines hands-on project management, operational leadership, team development, and client engagement. The position plays a key role in planning and delivering committee activities, coordinating stakeholders, and maintaining high-quality clinical research standards. You will work closely with biostatistical leaders, sponsors, project teams, vendors, and committee members to ensure timelines, deliverables, and regulatory expectations are met. The role also contributes to process improvement, reporting systems, business development, and departmental strategy. It offers the opportunity to influence clinical research operations while working across multiple projects and therapeutic areas.

• 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.

• 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.

• 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.