CTM II

Job Overview Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything we do, and we continuously seek ways to simplify and streamline our work so that we are easier to work with and easier to work for. Job 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 risks, protocol execution risks and risk mitigations related to the Risk Assessment and Categorization Tool (RACT). Reviews study scope of work, budget and protocol content, ensuring the clinical project team (CRAs/Central Monitors) is aware of contractual obligations and parameters. Uses clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates risks to clinical trial management deliverables (timeline, quality and budget) and activities outside contracted scope to the project manager. Employs strategic thinking and problem‑solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick‑Off Meetings. Serves as an escalation point for communications with investigator site staff and may interact with principal investigators or other site staff. May accompany CRA team members to sites for observation or conflict resolution. Collaborates with functional leaders (Study Start‑Up, Patient Recruitment, Data Management) to coordinate delivery handoffs and meet expected study milestones (site activation targets, enrollment targets, database lock timelines). Reviews and provides feedback on other functional plans (e.g., Data Management Plan, Communication Plan). Develops and maintains clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available to the clinical team, oversees UAT, and ensures access and audit trail reviews. Coordinates initial and ongoing training to the study team regarding protocol specifics, CRF completion, dashboards, Sponsor SOPs, clinical plans, guidelines, and data timelines. Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team conduct, and identifies risks to delivery or quality. Ensures quality of clinical monitoring, central monitoring and site management deliverables within a project and maintains visibility of progress using approved systems or tracking tools. Reviews project oversight dashboards and other clinical trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities, study team conduct, and data updates according to plan. Understands the monitoring strategy required for the study and participates in developing the study risk assessment plan. Ensures team members understand, comply with and deliver according to the monitoring strategy, CMP/SMP and risk plans. Reviews content and quality of site and central monitoring documentation (site monitoring calls, visit reports, site letters, central monitoring reports, etc.) to ensure they represent site management activities and appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Documents requested revisions and approvals in CTMS and ensures deliverables meet company/sponsor specifications and deadlines. Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management. Provides status updates on clinical deliverables and risks to clients, project management and leadership as per agreements. Provides solutions for obstacles in protocol execution and site management. Demonstrates understanding of other functions’ roles in achieving compliance and delivery (Data Management, Study Start‑Up, Patient Recruitment, Medical Monitoring, Pharmacovigilance, QA). Supports inspection readiness for clinical trial management scope. Oversees CRAs and Central Monitors, 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 activities to achieve data cut and lock deadlines. Provides feedback to line managers on staff performance, strengths and areas for development. May be assigned to larger, more complex trials. 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 in the achievement of project milestones. Demonstrated capability of working in an international environment. Demonstrated expertise in site management and monitoring (clinical or central). Preferred experience with risk‑based monitoring. Demonstrates understanding of clinical trial management financial principles and budget management. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Good communication, presentation and interpersonal skills among project team and with sites. Demonstrated ability to apply problem‑solving techniques to resolve complex issues and a risk‑management approach to identifying and mitigating potential threats. Moderate travel may be required, approximately 20%. Summary Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization’s facilities. They collaborate with principal investigators, client teams, and clinic operations, coordinate logistics and resource usage, track study progress in alignment with project milestones, deliverables and budget, and follow applicable regulations worldwide. Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at . #J-18808-Ljbffr