Syneos Health
Overview
Sr Clinical Trial Manager role 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, and we collaborate with teams to simplify and streamline work to help our customers achieve their goals. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll work with passionate problem solvers to accelerate the delivery of therapies and change lives. Responsibilities
Responsible for site management oversight, clinical and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversee site interactions from activation through closeout, including patient recruitment, investigator payments or related activities. Identify critical data and process risks and develop risk mitigations related to the Risk Assessment and Categorization Tool (RACT). Review study scope of work, budget and protocol content to ensure the clinical project team is aware of contractual obligations. Use operational data and metrics to identify risks to deliverables, escalating to the project manager any risks to timelines, quality or budget beyond contracted scope. Apply strategic thinking and problem-solving to 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 as needed, including accompanying CRA teams for site observation or conflict resolution. Collaborate with Study Start Up, Patient Recruitment and Data Management to coordinate handoffs and meet milestones (site activation, enrollment, database lock). Review and provide feedback on functional plans (e.g., Data Management Plan, Communication Plan) related to trial activities. Develop and maintain clinical study tools and templates (including the Clinical Monitoring Plan). Ensure CTMS and dashboards are set up for the team, oversee user acceptance testing as needed, and ensure access/audit trails are reviewed. Coordinate initial and ongoing training for the study team on protocol specifics, Case Report Form completion, dashboards, sponsor SOPs, data plans and timelines. Oversee resourcing for CRAs and Central Monitors, site assignments, and team conduct; identify risks to delivery or quality and ensure progress visibility using approved systems. Review project oversight dashboards and systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data reflects timely execution per plan. Understand monitoring strategy and participate in developing the study risk assessment plan. Ensure team compliance and delivery per CMP/SMP and risk plans. Review site and central monitoring documentation for accuracy and risk communication; ensure timely delivery per sponsor specifications and deadlines. Interacts with the client and other departments to communicate status and risks; provide solutions to obstacles in protocol execution and site management. Demonstrates understanding of other functions’ roles in compliance and delivery according to protocol, SOPs, ICH GCP and regulations. Supports Inspection Readiness for clinical trial management scope. Oversee CRAs and Central Monitors, assess process/training compliance, develop corrective action plans, and support data cut and lock activities. Provide feedback to line managers on staff performance and, where appropriate, mentor CTMs regarding clinical delivery and risk management. May be assigned to larger or more complex trials or coordinate activities for a team of CTMs across a portfolio of projects. 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 GCP/ICH Guidelines and regulatory requirements Strong computer skills and conflict resolution abilities Ability to apply problem-solving techniques and risk management approaches Critical thinking to identify issues and determine appropriate solutions Moderate travel required, approximately 20% Additional Information
We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, you’ll be added to our talent pipeline and considered should this role become available. Salary Range and Benefits: Syneos Health offers a comprehensive benefits package including health benefits, 401k, and paid time off where permitted. Details vary by location. Summary: Roles within Clinical Trial Management involve development, coordination and implementation of Phase 1 studies, collaboration with investigators and client teams, tracking progress against milestones and budget, and ensuring compliance with regulations globally.
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Sr Clinical Trial Manager role 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, and we collaborate with teams to simplify and streamline work to help our customers achieve their goals. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll work with passionate problem solvers to accelerate the delivery of therapies and change lives. Responsibilities
Responsible for site management oversight, clinical and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversee site interactions from activation through closeout, including patient recruitment, investigator payments or related activities. Identify critical data and process risks and develop risk mitigations related to the Risk Assessment and Categorization Tool (RACT). Review study scope of work, budget and protocol content to ensure the clinical project team is aware of contractual obligations. Use operational data and metrics to identify risks to deliverables, escalating to the project manager any risks to timelines, quality or budget beyond contracted scope. Apply strategic thinking and problem-solving to 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 as needed, including accompanying CRA teams for site observation or conflict resolution. Collaborate with Study Start Up, Patient Recruitment and Data Management to coordinate handoffs and meet milestones (site activation, enrollment, database lock). Review and provide feedback on functional plans (e.g., Data Management Plan, Communication Plan) related to trial activities. Develop and maintain clinical study tools and templates (including the Clinical Monitoring Plan). Ensure CTMS and dashboards are set up for the team, oversee user acceptance testing as needed, and ensure access/audit trails are reviewed. Coordinate initial and ongoing training for the study team on protocol specifics, Case Report Form completion, dashboards, sponsor SOPs, data plans and timelines. Oversee resourcing for CRAs and Central Monitors, site assignments, and team conduct; identify risks to delivery or quality and ensure progress visibility using approved systems. Review project oversight dashboards and systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data reflects timely execution per plan. Understand monitoring strategy and participate in developing the study risk assessment plan. Ensure team compliance and delivery per CMP/SMP and risk plans. Review site and central monitoring documentation for accuracy and risk communication; ensure timely delivery per sponsor specifications and deadlines. Interacts with the client and other departments to communicate status and risks; provide solutions to obstacles in protocol execution and site management. Demonstrates understanding of other functions’ roles in compliance and delivery according to protocol, SOPs, ICH GCP and regulations. Supports Inspection Readiness for clinical trial management scope. Oversee CRAs and Central Monitors, assess process/training compliance, develop corrective action plans, and support data cut and lock activities. Provide feedback to line managers on staff performance and, where appropriate, mentor CTMs regarding clinical delivery and risk management. May be assigned to larger or more complex trials or coordinate activities for a team of CTMs across a portfolio of projects. 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 GCP/ICH Guidelines and regulatory requirements Strong computer skills and conflict resolution abilities Ability to apply problem-solving techniques and risk management approaches Critical thinking to identify issues and determine appropriate solutions Moderate travel required, approximately 20% Additional Information
We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, you’ll be added to our talent pipeline and considered should this role become available. Salary Range and Benefits: Syneos Health offers a comprehensive benefits package including health benefits, 401k, and paid time off where permitted. Details vary by location. Summary: Roles within Clinical Trial Management involve development, coordination and implementation of Phase 1 studies, collaboration with investigators and client teams, tracking progress against milestones and budget, and ensuring compliance with regulations globally.
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