Clinical Trial Manager

Clinical Trial Manager - Sponsor Dedicated in Colombia Join to apply for the Clinical Trial Manager - Sponsor Dedicated in Colombia role at Syneos Health. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success by translating 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 that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives. 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. Might be responsible for identification of 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 and ensures the clinical project team (CRAs/Central Monitors) is aware of contractual obligations and parameters. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates risks related to timeline, quality and budget to the project manager and identifies activities outside the contracted scope. Employs strategic thinking and problem‑solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as 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, including accompanying CRA team members to sites for observation or conflict resolution. Collaborates with other functional leaders such as Study Start‑Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet study milestones such as site activation targets, enrollment targets and database lock timelines, and provides feedback on related functional plans. Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan, and ensures CTMS, dashboards and other systems are available for use by the clinical team, overseeing user acceptance testing (UAT) and audit trail reviews. Coordinates training for the study team regarding protocol specifics, CRF completion, dashboards, SOPs, clinical plans and guidelines, data plans and timelines for the study. Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team 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 visibility of progress using approved systems and tracking tools. Reviews project oversight dashboards and clinical trial systems (CTMS, EDC, eDiary, ePROs, Trial Master File, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and verify data updates. Understands the monitoring strategy required for the study, participates in the development of the study risk assessment plan, and is accountable for team compliance and delivery regarding monitoring strategy, CMP/SMP and risk plans. Reviews site and central monitoring documentation to ensure they represent management activities, convey risks, and meet delivery deadlines, documenting revisions in CTMS. Interacts with the client and other functional departments related to clinical monitoring and delivery, providing status updates on deliverables and risks, and proposing solutions for protocol execution obstacles. Demonstrates understanding of other functions’ roles in compliance and delivery, supporting inspection readiness for clinical trial management scope. Oversees CRAs and Central Monitors assigned to the study, assessing study‑specific process and training compliance, identifying emerging risks, and developing corrective action plans as needed. Provides feedback to line managers on staff performance, strengths and areas for development. 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. 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 applicable regulatory requirements. Must have good computer skills. Good communication, presentation and interpersonal skills with project team and sites. Strong conflict resolution skills. Ability to apply problem‑solving techniques to resolve complex issues and use a risk‑management approach. Critical thinking to determine cause and appropriate solution for identified issues. Moderate travel may be required, approximately 20 %. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills and/or education will also be considered so qualifications of incumbents may differ from those listed. The Company may determine what constitutes equivalent to the qualifications described. The information complies with all obligations imposed by the legislation of each country in which it operates, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate. Summary Roles within the Clinical Trial Management family are responsible for all aspects of developing, coordinating and implementing Phase 1 clinical research studies at the organization’s facilities. They collaborate with principal investigators, liaise with research subjects, client teams, investigators and clinic operations teams, plan logistics and resource usage, track study progress against milestones and budgets, and follow applicable regulations worldwide. Senior‑Level Mid‑Senior level Employment Type Full‑time Job Function Research, Analyst, and Information Technology Location Bogota, D.C., Capital District, Colombia #J-18808-Ljbffr