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Clinical Research Operations Manager
2 months ago
We are seeking a highly skilled Clinical Research Operations Manager to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for overseeing site management and monitoring activities to ensure the successful execution of clinical trials.
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.
- Risk Management: Oversees site interactions post-activation through site closeout and identifies critical data and process, protocol execution risks, and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
- Study Scope and Budget: 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.
- Operational Data Analysis: Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables.
- Escalation and Communication: 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.
- Strategic Thinking and Problem-Solving: Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Client and Stakeholder Management: Interacts with the client and other functional departments related to clinical monitoring, central monitoring, and site management activities and deliverables.
- Quality Assurance and Inspection Readiness: Supports Inspection Readiness for clinical trial management scope and oversees CRAs and Central Monitors assigned to the study.
- Education: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Leadership and Team Management: Demonstrated ability to lead and align teams in the achievement of project milestones.
- International Experience: Demonstrated capability of working in an international environment.
- Site Management and Monitoring Expertise: Demonstrated expertise in site management and monitoring (clinical or central).
- Regulatory Knowledge: Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Communication and Interpersonal Skills: Good communication, presentation, and interpersonal skills among project team and with sites.
- Conflict Resolution: Strong conflict resolution skills.
- Problem-Solving and Risk Management: 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.
