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
- Senior Clinical Trial Manager overseeing site management and monitoring for biopharmaceutical solutions organization. Responsible for clinical monitoring, patient safety, and regulatory compliance in South Africa.
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/CeMs) 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) and any activities and requests which are out of contracted scope
- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
- Participates and presents in key meetings such as Kick Off Meeting
- Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members
- Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones
- Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities
- Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan
- Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team
- Ensures access and audit trail reviews are conducted as required
- Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study
- Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct
- Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and/or tracking tools
- Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects
- Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan
- Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy
- Reviews the content and quality of site and central monitoring documentation to ensure they represent site management activities and conduct
- Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables
- Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements
- Provides solutions for obstacles in protocol execution and site management
- Supports Inspection Readiness for clinical trial management scope
- Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance
- Develop and support execution of corrective action plans at site and study level
- Provides feedback to line managers on staff performance including strengths as well as areas for development.
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
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
- Strong conflict resolution skills
- Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
Benefits
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Job title
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Experience level
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Degree requirement
Tech skills
Location requirements
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