Director, Clinical Data Management

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.