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Location: Bogota, DC, Colombia

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, or related activities.
- Identifies critical data and process, protocol execution risks and risk mitigations related to the Risk Assessment and Categorization Tool (RACT).
- Reviews study scope of work, budget and protocol content to ensure 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 to the project manager regarding timeline, quality and budget, and activities outside contracted scope.
- Employs strategic thinking and problem‑solving 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 interact on the phone or in person 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 study milestones such as site activation targets, enrollment targets and database lock timelines; reviews and provides feedback on other functional plans.
- Responsible for development and ongoing maintenance of clinical study tools and templates,



including the Clinical Monitoring Plan; ensures CTMS, dashboards and other systems are ready and oversees user acceptance testing (UAT) as needed.
- Coordinates training to the study team on protocol specifics, CRF completion, dashboards, sponsor SOPs, clinical plans and data timelines.
- Oversees resourcing allocations for CRAs and Central Monitors, site assignments and team conduct; identifies risks to delivery or quality.
- Ensures quality of clinical monitoring, central monitoring and site management deliverables; maintains visibility via approved systems and tracking tools.
- Reviews dashboards and clinical trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data are updated promptly.
- Understands monitoring strategy and participates in development of the study risk assessment plan; ensures team compliance with monitoring strategy and risk plans.
- Reviews site and central monitoring documentation for content and quality, records revisions in CTMS, and ensures deliverables meet sponsor or company specifications and deadlines.
- Interacts with the client and functional departments regarding clinical monitoring deliverables; provides status updates and solutions for protocol execution and site management obstacles.




- Demonstrates understanding of other functions' roles in compliance; supports Inspection Readiness for clinical trial management scope.
- Oversees CRAs and Central Monitors; assesses training compliance, identifies emerging risks, develops corrective action plans, and supports data cut and lock deadlines.
- Provides performance feedback to line managers and 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 to achieve project milestones.
- Experience working in an international environment.
- Expertise in site management and clinical or central monitoring.
- Preferred experience with risk‑based monitoring.
- Understanding of clinical trial management financial principles and budget management.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Good computer skills.
- Strong communication, presentation and interpersonal skills with project team and sites.
- Effective conflict resolution skills.
- Ability to apply problem‑solving techniques and risk‑management approaches to mitigate threats to successful project conduct.
- Demonstrated critical thinking to determine causes and appropriate solutions for issues.
- Moderate travel may be required (approximately 20%).

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.

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Postúlate en Kit Empleo: kitempleo.com.co/empleo/1azf8k

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