Clinical Trial Manager – Senior
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Job Description
Clinical Trial Manager responsible for oversight and monitoring of clinical trials ensuring patient safety and compliance. Collaborating with teams at Syneos Health to deliver successful outcomes in trial management.
Responsibilities:
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
- Oversees site interactions post activation through site closeout
- Responsible for identification of critical data and process, protocol execution risks and risk mitigations
- Reviews the study scope of work, budget and protocol content
- Uses operational data, metrics and reports to identify risks to clinical trial management deliverables
- Escalates risks to the project manager and implements risk mitigations
- Participates and presents in key meetings
- Provides status updates on the clinical deliverables and risks
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 in the achievement of project milestones
- Demonstrated capability of working in an international environment
- Demonstrated expertise in site management and monitoring (clinical or central)
- Preferred experience with risk-based monitoring
- Demonstrates understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
Benefits:
- career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
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