Clinical Trial Manager
hace 1 día
We are seeking a highly skilled Clinical Trial Manager to join our team at Syneos Health. As a Clinical Trial Manager, you will be responsible for overseeing site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
Key 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, including patient recruitment, investigator payments, and other related activities.
- Identifies 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 to ensure 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 that 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 the 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.
- Ensures CTMS, dashboards, and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
- 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.
- 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 maintains 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 according to plan.
- Understands the monitoring strategy required for the study and, where required, 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, CMP/SMP, and risk plans.
- Reviews the content and quality of site and central monitoring documentation to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.
- 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.
- Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.
- 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, CMP compliance, and identifies emerging risks.
- May develop and support execution of corrective action plans at site and study level.
- Supports and completes activities to achieve data cut and lock deadlines.
- Provides feedback to line managers on staff performance, including strengths and areas for development.
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Ability to lead and align teams in the achievement of project milestones.
- Capable of working in an international environment.
- Previous clinical trial experience in site management.
- Preferred experience with risk-based monitoring and clinical or central monitoring.
- Familiar with financial principles and budget management practices.
- 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.
- Basic conflict resolution skills.
- 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%.
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