Clinical Research Associate monitoring Canadian clinical trials for Parexel, a global clinical research organization. Managing site relationships, compliance, data quality, and study delivery.
About the role
- Clinical Data Science Manager leading data scientists, client accounts, and global clinical-trial projects. Ensuring data quality, regulatory compliance, staffing, budgets, and operational delivery at Syneos Health.
Responsibilities
- Line manage, develop, and remain accountable for Clinical Data Scientists in the assigned team
- Manage client relationships for assigned accounts
- Meet operational targets including quality, performance, utilization, retention, and training
- Ensure contracted project services meet contracts, client expectations, quality standards, SOPs, regulatory guidelines, and legal requirements
- Oversee multiple projects ranging from single-service studies to multiple global projects within a program
- Serve as primary escalation and relationship-management contact for assigned clients and projects
- Oversee account financial health, scope, budgets, resources, and forecasting
- Review project documentation for quality and consistency
- Guide functional leads in clinical data quality oversight and risk monitoring
- Support development of technologies, tools, and applications for detecting unreliable clinical-trial data
- Participate in quality issues, CAPAs, and audit findings
- Interview, onboard, train, mentor, and coach staff
- Manage team resources, workloads, assignments, billable and non-billable time, productivity, timeliness, and quality
- Prepare for and run Project Review Meetings
- Lead staff through client or regulatory audits
- Represent Clinical Data Science in business-development and client meetings
- Contribute to project budgets and scopes of work
- Develop training materials and perform staff training
- Participate in developing departmental technologies, SOPs, processes, and procedures
- Perform other assigned work-related duties
Requirements
- BA/BS in biological sciences, computer sciences, mathematics, data sciences, and/or related disciplines in the natural science/health care space, or equivalent relevant work experience
- MS degree preferred
- Strong knowledge of the drug development process and its impact on data quality
- Knowledge of risk-based approaches, biometrics procedures, and workflows
- Strong project management skills and knowledge of project management methodologies
- Leadership and effective mentoring skills
- Ability to deal effectively with clients and internal stakeholders
- Excellent written and spoken communication, presentation, and interpersonal skills
- Experience in Clinical Data Science practices and relational database management software systems
- Demonstrated experience working within a team matrix structure
- Demonstrated experience making effective decisions and managing multiple priorities in a highly dynamic environment
- Knowledge of ICH/GCP regulatory requirements for clinical studies
- Ability to travel as necessary, up to 25%
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Company car or car allowance
- Medical, dental, and vision health benefits
- Company match 401(k)
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time
- Reasonable accommodations, when appropriate
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