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Clinical Trial Manager
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Clinical Trial Manager - Sponsor Dedicated in Colombia Join to apply for the Clinical Trial Manager - Sponsor Dedicated in Colombia role at Syneos Health . Clinical Trial Manager - Sponsor Dedicated in Colombia 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 that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us 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. Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we’re able to create a place where everyone feels like they belong. 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 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 and ensures the clinical project team 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 to the project manager and any activities outside 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 interact on the phone or in person with principals investigators or other site staff. May accompany CRA team members to sites for observation or conflict resolution. Collaborates with other functional leaders (Study Start Up, Patient Recruitment and Data Management) to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. 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 the clinical team. Coordinates initial and ongoing training to the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor SOPs, clinical plans and guidelines, data plans and 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 the clinical monitoring, central monitoring and site management deliverables within a project and maintains proper visibility of progress by using approved systems and tracking tools. Reviews the 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 per 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 team members’ compliance and delivery according to the monitoring strategy, CMP/SMP and risk plans. Reviews the content and quality of site and central monitoring documentation to ensure they convey risks to protocol/GCP compliance, trial conduct, patient safety or data integrity; documents revisions and approvals in CTMS. Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and delivers status updates on deliverables and risks. 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, assessing study‑specific process and training compliance, CMP compliance and emerging risks; may develop and support execution of corrective action plans at site and study level. Provides feedback to line managers on staff performance and may be assigned to larger, more complex trials. Qualifications Bachelor’s degree or RN in a related field or an 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. Understanding of clinical trial management financial principles and budget management. Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements. Must demonstrate good computer skills. Good communication, presentation and interpersonal skills with the project team and sites. Strong conflict resolution skills. Ability to apply problem‑solving techniques to resolve complex issues and employ a risk‑management approach. Demonstrates critical thinking to determine causes and appropriate solutions. Moderate travel may be required, approximately 20 %. Get to know Syneos Health Over the past 5 years, we have worked with 94 % of all Novel FDA Approved Drugs, 95 % of EMA Authorized Products and over 200 studies across 73 000 sites and 675 000+ trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health at . 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 in the Job Description. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. 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, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plan logistics and resource usage. They track study progress in alignment with project milestones, client deliverables, and budget, and follow applicable regulations globally and by region. Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Syneos Health by 2x. 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