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Clinical Trial Management Specialist
2 months ago
We are seeking a highly skilled Clinical Trial Operations Manager to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for overseeing the management of clinical trials, ensuring compliance with regulatory requirements, and driving project success.
Key Responsibilities- Site Management Oversight: Responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
- Project Coordination: Oversees site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other related activities.
- Risk Management: Identifies critical data and process, protocol execution risks, and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
- Study Planning: 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.
- Quality Assurance: Ensures quality of the clinical monitoring, central monitoring, and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and/or tracking tools.
- Communication: Interacts 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 as per departmental or study agreements.
- Education: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Experience: Demonstrated ability to lead and align teams in the achievement of project milestones, with a minimum of 5 years of experience in clinical trial management.
- Skills: Demonstrated expertise in site management and monitoring (clinical or central), with a strong understanding of clinical trial management financial principles and budget management.
- Regulatory Knowledge: Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Communication: Good communication, presentation, and interpersonal skills among project team and with sites.
