Clinical Trial Manager II – Study Manager, RWE
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Job Description
Clinical Trial Manager overseeing site management and monitoring deliverables for clinical trials. Collaborating with various teams to ensure adherence to compliance and patient safety.
Responsibilities:
- Responsible for site management oversight, clinical monitoring, and deliverables
- Oversees site interactions and post-activation processes
- Identifies critical data and process risks and mitigations
- Reviews study scope of work, budget, and protocol content
- Escalates risks to the project manager
- Proposes and implements risk mitigations
- Collaborates with functional leaders to coordinate delivery
- Develops and maintains clinical study tools and templates
- Ensures systems for clinical team utilization and testing
- Coordinates training regarding protocol specificities
- Reviews quality of monitoring documentation
- Provides status updates and solutions for protocol execution
Requirements:
- Bachelor’s degree or RN in a related field or equivalent
- Demonstrated ability to lead and align teams in project milestones
- Demonstrated capability in an international environment
- Expertise in site management and monitoring
- Preferred experience with risk-based monitoring
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Good computer skills
- Strong conflict resolution skills
- Critical thinking to resolve complex issues
- Moderate travel required, approximately 20%
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture allowing authenticity
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