Senior Clinical Research Associate managing oncology trial sites for Worldwide Clinical Trials, a global contract research organization. Overseeing study start - up, site maintenance, safety reporting, and closeout across Canada.
About the role
- Clinical Trial Manager overseeing site, clinical and central monitoring for Syneos Health’s integrated life-sciences services. Managing risks, compliance, study systems and delivery milestones across clinical trials.
Responsibilities
- Oversee site management, clinical monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity
- Oversee site interactions from activation through closeout, including patient recruitment and investigator payments where applicable
- Identify clinical trial management risks and develop or implement risk mitigations
- Review study scope of work, budget and protocol content; ensure the clinical project team understands contractual obligations and parameters
- Escalate risks to timelines, quality, budget and out-of-scope activities to the project manager
- Participate in and present at key meetings, including Kick Off Meetings
- Serve as an escalation point for investigator site staff communications and interact with principal investigators and site staff
- Collaborate with Study Start Up, Patient Recruitment, Data Management and other functional leaders 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 as needed
- Coordinate initial and ongoing study-team training
- Oversee CRA and Central Monitor resourcing, site assignments, conduct and delivery risks
- Monitor quality and visibility of clinical monitoring, central monitoring and site management deliverables using approved systems and tracking tools
- Review CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central-monitoring dashboards to oversee site and patient activities
- Ensure compliance with the monitoring strategy, CMP/SMP and risk plans
- Review site and central monitoring documentation for quality, completeness and risks to compliance, patient safety and data integrity
- Interact with clients and functional departments regarding clinical monitoring and site management deliverables
- Provide status updates on clinical deliverables and risks to clients, project management and leadership
- Support inspection readiness, corrective action plans, data cut and database lock activities
- Oversee assigned CRAs and Central Monitors and assess process, training and CMP compliance
- Provide performance feedback to line managers
Requirements
- Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
- Ability to lead and align teams to achieve project milestones
- Ability to work in an international environment
- Previous clinical trial experience in site management
- Preferred experience with risk-based monitoring and clinical or central monitoring
- Familiarity with financial principles and budget management practices
- Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
- Good computer skills
- Good communication, presentation and interpersonal skills
- Basic conflict resolution skills
- Problem-solving and risk-management ability for complex clinical research issues
- Critical-thinking ability to identify causes and appropriate solutions
- Moderate travel availability, approximately 20%
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Comprehensive resources including emerging technologies, data, science and knowledge sharing
- Collaboration with specialized therapeutically or functionally aligned teams
- Diverse career paths and employment opportunities
- Reasonable accommodations, when appropriate
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