Sr. Clinical Trial Manager

Overview Sr. Clinical Trial Manager - Mexico at Syneos Health Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model places the customer and the patient at the center of everything we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies and to change lives. Work here matters everywhere. 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. This may include patient recruitment, investigator payments or other related activities. May identify critical data and process risks and apply risk mitigations related to the Risk Assessment and Categorization Tool (RACT). Review the study scope of work, budget and protocol content to ensure the clinical project team is aware of contractual obligations and parameters. Use prior clinical experience and metrics to identify risks to deliverables. Escalate risks to the project manager when necessary. Employ strategic thinking and problem-solving to propose and implement risk mitigations. Participate in key meetings such as Kick Off. Serve as an escalation point for communications with investigator site staff and may interact with principal investigators or site staff. May accompany CRA team members to sites for observation or conflict resolution. Collaborate with functional leaders (e.g., Study Start Up, Patient Recruitment, Data Management) to coordinate handoffs and meet study milestones such as site activation, enrollment, and database lock timelines. Review and provide feedback on related plans (e.g., Data Management Plan, Communication Plan). Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan. Ensure CTMS and dashboards are set up and available for the team; oversee user acceptance testing and audit trail reviews as required. Coordinate initial and ongoing training to the study team regarding protocol specifics, CRF completion, dashboards, SOPs, data plans and timelines. Oversee resourcing allocations for CRAs and Central Monitors, site assignments, and study team conduct. Ensure quality of deliverables and visibility of progress through approved systems/tools. Review project oversight dashboards and trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, central monitoring dashboards) to oversee site and patient activities and ensure data reflect timely execution of operational aspects. Understand and participate in the monitoring strategy for the study. Ensure team members understand and comply with the monitoring strategy, CMP/SMP, and risk plans. Review site and central monitoring documentation (site monitoring calls/reports, letters, central monitoring reports, correspondence) to ensure they convey risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document revisions in CTMS and meet deadlines. Interact with the client and other functions to provide status updates on deliverables and risks. Propose solutions for obstacles in protocol execution and site management. Demonstrate understanding of other functions’ roles in achieving compliance and delivery according to protocol and regulatory requirements. Support inspection readiness for clinical trial management scope. Oversee CRAs and Central Monitors, assess process/training compliance, and develop corrective action plans as needed. Support data cut and lock deadlines. Provide feedback to line managers on staff performance and development. May be assigned to larger or more complex trials, or coordinate activities for a team of CTMs across a portfolio. May coach CTMs on clinical delivery and risk management. 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 to achieve project milestones Experience working in an international environment Expertise in site management and monitoring (clinical or central) Preferred experience with risk-based monitoring Understanding of clinical trial management financial principles and budget management Knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements Strong computer skills Good conflict resolution skills Ability to apply problem-solving techniques to resolve complex issues and use risk management to mitigate threats Critical thinking to identify causes and appropriate solutions Moderate travel, approximately 20% #J-18808-Ljbffr