Description
Syneos Health is seeking a CTM II - Sr.CTM for FSP BU, South Korea.
The Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Job 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) 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.
- Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
- 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, and identifies risks to delivery or quality.
- Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress.
- 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, where required, participates in the development of the study risk assessment plan.
- Reviews the content and quality of site and central monitoring documentation.
- Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
- Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
- Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
- Provides feedback to line managers on staff performance including strengths as well as areas for development.
Qualifications:
- 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
- Good communication, presentation and interpersonal skills among project team and with sites
- 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.
- Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
- Moderate travel may be required, approximately 20%