Clinical Research Nurse enhancing pediatric oncology care at Monash Children's Hospital. Collaborating with medical staff and managing patient flow for effective cancer treatment.
About the role
- Clinical Trial Manager overseeing site management and monitoring deliverables for clinical trials. Ensuring compliance and data integrity in a hybrid work environment based in Bucharest.
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.
- May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
- Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget).
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 and total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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