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 Trial Manager overseeing clinical monitoring, site management, risk mitigation and compliance. Supporting Syneos Health’s drug development and commercialization services for life sciences customers.
Responsibilities
- Provide site management oversight, clinical monitoring and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance and data integrity
- Oversee site interactions from post-activation through site closeout, including patient recruitment and investigator payments
- Identify critical data, process and protocol execution risks and develop risk mitigations
- Review study scope of work, budget and protocol content; ensure clinical project teams understand contractual obligations and parameters
- Identify and escalate risks affecting timelines, quality, budget and contracted scope
- Participate in and present at key meetings, including Kick Off Meetings
- Serve as an escalation point for investigator site communications and interact with principal investigators and site staff
- Coordinate with Study Start Up, Patient Recruitment and Data Management to meet study milestones
- Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan
- Ensure CTMS, dashboards and other systems are configured and available, including overseeing UAT and access/audit trail reviews
- Coordinate initial and ongoing study-team training
- Oversee CRA and Central Monitor resourcing, site assignments and conduct
- Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables
- Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS and central monitoring dashboards
- Oversee compliance with monitoring strategies, CMP/SMP and risk plans
- Review site and central monitoring documentation and ensure timely delivery to company or sponsor specifications
- Provide client, project management and leadership status updates on deliverables and risks
- Support inspection readiness for clinical trial management scope
- Oversee CRAs and Central Monitors, assess compliance and identify emerging risks
- Develop and support corrective action plans and activities to achieve data cut and lock deadlines
- Provide performance feedback to line managers
Requirements
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Demonstrated ability to lead and align teams in the achievement of project milestones
- Demonstrated capability of working in an international environment
- Demonstrated expertise in site management and monitoring (clinical or central)
- Preferred experience with risk-based monitoring
- Understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills
- Good communication, presentation and interpersonal skills
- Strong conflict resolution skills
- Ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach
- Critical thinking to determine causes and appropriate solutions
- Moderate travel may be required, approximately 20%
- Equivalent experience, skills, and/or education will also be considered
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations for employees or applicants with disabilities, when appropriate
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