Job Description
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 outsid...