About the company
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 Science based in Canada.
Responsibilities
- Lead, manage, mentor, and develop Clinical Data Science professionals, including onboarding, performance management, training, coaching, and career development.
- Oversee multiple clinical projects ranging from individual studies to complex global programs, ensuring activities meet contractual commitments, quality standards, timelines, and applicable regulations.
- Serve as a primary escalation and relationship-management contact for assigned clients and projects.
- Monitor project scope, budgets, resources, forecasting, utilization, productivity, timelines, and overall financial health.
- Guide Clinical Data Science leads in maintaining data quality and identifying operational and clinical risks.
- Ensure project documentation is maintained appropriately and that trial master files remain inspection-ready.
- Support the identification, analysis, and resolution of quality issues, CAPAs, audit findings, and regulatory or client observations.
- Lead or support client and regulatory audits.
- Participate in business development activities, client meetings, proposals, scope development, and project budget planning.
- Contribute to the development of technologies, tools, SOPs, processes, training materials, and procedures.
Requirements
- Bachelor’s degree in biological sciences, computer sciences, mathematics, data sciences, or a related natural science or healthcare discipline; a master’s degree is preferred.
- Strong knowledge of the drug development process and its relationship to clinical data quality, including risk-based approaches, biometrics procedures, and workflows.
- Demonstrated experience in Clinical Data Science practices and relational database management systems.
- Strong project management capabilities and familiarity with established project management methodologies.
- Experience leading, mentoring, and developing Clinical Data Science professionals.
- Knowledge of ICH/GCP requirements and regulatory expectations for clinical studies.
- Excellent written and verbal communication, presentation, interpersonal, influencing, and problem-solving skills.
- Experience working effectively within matrixed, cross-functional teams.
- Ability to travel as required, up to approximately 25%.
Conditions
- Competitive base salary range of $95,000–$210,900.
- Medical, dental, and vision health benefits.
- Employer-matched 401(k) retirement plan.
- Eligibility to participate in an Employee Stock Purchase Plan.
- Potential eligibility for commissions or bonuses.
- Flexible paid time off and sick time.
- Potential company car or car allowance.
- Remote work arrangement available for pre-approved locations in Canada.
- Professional development opportunities.