Senior Clinical Trial Manager II
New
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Syneos HealthBiopharmaceutical
Mexico, Argentina, Brasil, Chile, Colombia - RemoteFull-TimeSenior
Salary not disclosed
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Job Details
- Required Skills
- Budget managementRisk Management
Requirements
- Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
- Demonstrated expertise in clinical or central site management and monitoring.
- Strong knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
- Proven ability to lead and align teams toward project milestones.
- Demonstrated experience working in an international environment.
- Strong problem-solving, conflict resolution, and critical thinking skills.
- Experience applying risk management approaches to clinical trial conduct.
- Understanding of financial principles and budget management for clinical trials.
- Good computer skills and ability to use clinical trial management systems.
- Approximately 20% travel requirement.
Responsibilities
- Manage site oversight, clinical monitoring, and central monitoring deliverables focusing on safety, compliance, and data integrity.
- Oversee site activities from post-activation through closeout, including patient recruitment and investigator payments.
- Execute risk assessment and mitigation strategies using the Risk Assessment and Categorization Tool (RACT).
- Monitor study scope, budget, and protocol content to ensure alignment with contractual obligations.
- Collaborate with functional teams like Data Management, Study Start-Up, and Patient Recruitment to meet study milestones.
- Coordinate team training on protocols, CRFs, dashboards, and SOPs.
- Oversee resource allocation for CRAs and Central Monitors, assessing performance and compliance.
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