Clinical Trial Manager – Project Management
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Job Description
Clinical Trial Manager overseeing sponsor-dedicated clinical monitoring and site management for Syneos Health, a global life sciences services organization. Ensuring compliance, data integrity, risk mitigation and study milestone delivery in Argentina.
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 recruitment and investigator payments
- Identify clinical trial management risks and develop or implement mitigations
- Review scope of work, budget and protocol content; ensure the clinical project team understands contractual obligations and parameters
- Escalate risks to timelines, quality and budget, and activities outside contracted scope
- Participate in and present at key meetings, including Kick Off Meetings
- Serve as an escalation point for investigator site staff 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 training for the study team
- Oversee CRA and Central Monitor resourcing, site assignments and team conduct
- Monitor quality, progress and compliance of clinical monitoring, central monitoring and site management deliverables
- Review clinical trial systems and dashboards to oversee site and patient activities and timely operational execution
- Review site and central monitoring documentation, request revisions and document approvals in CTMS
- Interact with clients and functional departments regarding clinical monitoring and site management deliverables
- Provide status updates on deliverables and risks to clients, project management and leadership
- Provide solutions for protocol execution and site management obstacles
- Support inspection readiness, corrective action plans, and data cut and lock deadlines
- Assess study-specific process, training and monitoring-plan compliance and identify emerging risks
- 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 toward project milestones
- Capability to work in an international environment
- Expertise in clinical site management and monitoring
- Preferred experience with risk-based monitoring
- Understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and 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 use a risk management approach
- Critical thinking to determine causes and appropriate solutions
- Moderate travel may be required, 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
- Collaboration with colleagues from across the world
- Comprehensive resources including emerging technologies, data, science and knowledge sharing
- Multiple career paths and employment opportunities
- Reasonable accommodations, when appropriate
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