# Clinical Trial Manager l or ll **Company**: Syneos Health **Location**: HUN-Remote **Work arrangement**: remote **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/HUN-Remote/Clinical-Trial-Manager-l-or-ll--Home-based-Hungary_25113639?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_40fbd864-2fd ## Description Syneos Health is seeking a Clinical Trial Manager l or ll to work remotely from Hungary. The Clinical Trial Manager will be responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies. Key responsibilities include: - Collaborating with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams - Planning logistics and resource usage - Tracking study progress in alignment with project milestones, client deliverables, and budget - Following applicable regulations globally and by region - Overseeing site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity - Reviewing the study scope of work, budget and protocol content and ensuring the clinical project team is aware of the contractual obligations and parameters - Using prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables - Escalating to the project manager any risks to clinical trial management deliverables - Employing strategic thinking and problem-solving skills to propose and implement risk mitigations - Participating and presenting in key meetings such as Kick Off Meeting - Serving as an escalation point for communications with investigator site staff - Collaborating with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones - Developing and maintaining clinical study tools and templates, including the Clinical Monitoring Plan - Coordinating initial and ongoing training to the study team regarding protocol specificities, Case Report Form completion, dashboards, Sponsor Standard Operating Procedures, clinical plans and guidelines, data plans and timelines for the study - Overseeing resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct - Ensuring quality of the clinical monitoring, central monitoring and site management deliverables within a project - Reviewing 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 - Understanding the monitoring strategy required for the study and participating in the development of the study risk assessment plan - Reviewing the content and quality of site and central monitoring documentation - Interacting with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables - Providing status updates on the clinical deliverables and risks to clients, project management and leadership - Demonstrating understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations - Overseeing CRAs and Central Monitors assigned to the study and routinely assessing study-specific process and training compliance - Providing 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 - 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 - Critical thinking to determine the cause and appropriate solution in the identification of issues - Moderate travel may be required, approximately 20% ## Skills ### Required - Good Clinical Practice - ICH Guidelines - clinical trial management - budget management - risk-based monitoring - conflict resolution - problem solving --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/HUN-Remote/Clinical-Trial-Manager-l-or-ll--Home-based-Hungary_25113639?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)