Clinical Trial Manager (Sponsor dedicated) - Experience in project management and previous experience as CRA - Argentina Home Based
Remote · Argentina
Job Summary
Clinical Trial Manager 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 from post-activation through closeout, may involve patient recruitment and investigator payments. Utilizes prior clinical experience, metrics and risk assessments (RACT) to identify risks and implement mitigations; reviews scope of work, budgets and protocol content to align with contractual obligations. Serves as escalation point for communications with investigators and site staff; coordinates with CRAs/Central Monitors and cross-functional teams (Study Start Up, Recruitment, Data Management) to hit milestones (activation targets, enrollment targets, database lock). Contributes to development of study tools/templates (e.g., Clinical Monitoring Plan) and ensures CTMS/EDC/eDiary/ePRO/TMF systems are configured and used, including UAT. Manages resource allocations for CRAs/Central Monitors, oversees study dashboards and ensures timely delivery of all operational aspects. Requires a Bachelor's degree or RN in a related field, international experience, and travel familiarity; knowledge of GCP/ICH guidelines and regulatory requirements; strong problem-solving, communication and conflict-resolution skills.
Required 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
- Must demonstrate good computer skills
- Good communication, presentation and interpersonal skills among project team and with sites
- Strong conflict resolution skills
- Demonstrated ability to apply problem solving techniques and risk management to trials
- Moderate travel may be required ~20%
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