This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Clinical Data Management based in Canada.
This is a senior leadership opportunity overseeing clinical data management operations within a growing global clinical research environment.
The role is responsible for ensuring clinical databases are complete, accurate, secure, and compliant with international regulatory standards.
You will lead operational strategy, resource planning, budgets, quality processes, and the delivery of high-profile clinical data projects.
The position combines technical expertise with people leadership, client relationship management, and cross-functional collaboration.
You will work closely with Clinical Operations, Biostatistics, Statistical Programming, Quality Assurance, Project Management, and Medical Writing teams.
A key focus will be driving process improvement, adopting new technologies, and establishing best-in-class data management standards.
The role can be performed remotely from anywhere in Canada or on-site in Markham, Ontario.
Accountabilities:
- Establish and oversee clinical data operations to ensure complete, valid, secure, and compliant clinical databases that meet corporate and regulatory requirements.
- Develop, manage, and continuously monitor clinical data management budgets and resource plans, ensuring effective allocation of resources and achievement of divisional objectives.
- Manage clinical data management project portfolios in collaboration with senior leadership while maintaining strong client relationships and contributing to new business proposals and project bids.
- Plan and direct the availability and quality of clinical data capture instruments and databases, covering CRF design, database definition, administration, data entry, data management, storage, and QC/QA activities.
- Integrate Clinical Data Management activities with Quality Assurance and Compliance, Project Management, Clinical Operations, Biostatistics, Statistical Programming, and Medical Writing to optimize delivery and organizational effectiveness.
- Conduct competitive benchmarking of clinical data operations and identify opportunities to adopt leading industry practices.
- Establish, maintain, and oversee clinical data management guidelines, procedures, and standards aligned with industry best practices and regulatory expectations.
- Lead the evaluation and implementation of new systems, technologies, standards, and processes designed to improve data capture, management, quality, and operational efficiency.
- Recruit, train, motivate, and develop clinical data management professionals, fostering strong technical expertise and high performance.
- Conduct performance reviews and oversee staff development, training programs, and succession planning.
- Plan and control resources to support departmental and organizational goals while maintaining operational effectiveness.
- Provide strategic and technical leadership on high-profile clinical data management initiatives and complex projects.
- Champion continuous improvement and identify opportunities to increase efficiency, strengthen quality, and enhance client outcomes.
Requirements
- Master’s degree in Computer Science, Biostatistics, Mathematics, Life Sciences, or a related discipline; equivalent experience and demonstrated expertise may be considered.
- At least 15 years of experience in Clinical Data Management, including a minimum of 3 years of people or line management experience.
- Comprehensive knowledge of systems, processes, and operations used to collect, store, process, and perform QC/QA on clinical data.
- Strong understanding of international clinical data standards and regulatory requirements, including 21 CFR Part 11 and ICH guidelines.
- Demonstrated experience designing and implementing Standard Operating Procedures (SOPs) for Clinical Data Management.
- Strong people leadership capabilities, with proven experience managing teams and collaborating effectively across multiple functional areas and organizational levels.
- Excellent analytical, creative problem-solving, and decision-making skills, with the ability to address complex clinical data challenges.
- Strong client relationship management skills and the ability to communicate effectively with both technical and business stakeholders.
- Demonstrated commitment to process improvement and the ability to develop and implement strategic operational processes that improve efficiency and performance.
- Experience providing technical leadership and managing high-profile or complex clinical data projects.
- Strong written and verbal communication skills, with the ability to present complex information clearly to professional and administrative audiences.
- Experience evaluating and implementing new systems, processes, standards, and technologies within Clinical Data Management.
- Ability to develop and implement standards and procedures that improve the effectiveness, quality, and efficiency of clinical data operations.
- Experience contributing to business development, client proposals, or future business opportunities is preferred.
Benefits
- Estimated salary range of CAD $170,000–$190,000.
- Remote work opportunity from anywhere in Canada, in accordance with the applicable work-from-home policy.
- Option for an on-site role in Markham, Ontario.
- Senior leadership position with significant influence over clinical data management strategy and operations.
- Opportunity to work on complex clinical research programs supporting pharmaceutical, biotechnology, and medical device development.
- Exposure to international clinical research standards, advanced data management systems, and evolving industry practices.
- Opportunities to lead and develop high-performing clinical data management teams.
- Cross-functional collaboration with Clinical Operations, Biostatistics, Statistical Programming, Quality Assurance, Project Management, and Medical Writing professionals.
- Opportunity to drive process improvement, technology adoption, and operational innovation.
- Inclusive workplace committed to dignity, independence, integration, equal opportunity, and accessibility.
- Reasonable accommodations are available throughout the recruitment and selection process for candidates with disabilities.