Clinical Trial Manager II / Senior Clinical Trial Manager
New
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Syneos HealthBiopharmaceutical solutions
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, training, and experience.
- Demonstrated expertise in clinical or central site management and monitoring.
- Proven ability to lead and align teams to achieve project milestones.
- Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
- Demonstrated capability of working in an international environment.
- Strong conflict resolution, problem-solving, and risk management skills.
- Familiarity with clinical trial management financial principles and budget management.
- Good computer skills.
- Effective communication, presentation, and interpersonal skills.
- Preferred: Experience with risk-based monitoring.
- Ability to travel approximately 20% of the time.
Responsibilities
- Oversee site management, clinical monitoring, and central monitoring to ensure patient safety, protocol compliance, and data integrity.
- Manage site interactions from activation through closeout, including recruitment and investigator payments.
- Identify risks to clinical trial deliverables using RACT and operational metrics, escalating to project managers as necessary.
- Ensure the clinical project team is aligned with contractual obligations, study scope, and budgets.
- Develop and maintain clinical study tools, such as the Clinical Monitoring Plan, and oversee system setup for the study team.
- Coordinate team training on protocol, SOPs, and data systems, and oversee resourcing for CRAs and Central Monitors.
- Review monitoring reports and correspondence to ensure quality and compliance with regulatory standards.
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