Description
Syneos Health is seeking a Clinical Trial Manager II to join their team remotely from Ciudad de Mexico.
The Clinical Trial Manager II is responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
Key responsibilities include:
- Overseeing site interactions post-activation through site closeout
- Identifying critical data and processes, protocol execution risks, and risk mitigations
- Reviewing study scope of work, budget, and protocol content
- Using prior clinical experience, operational data, metrics, and reports to identify risks
- Escalating risks to clinical trial management deliverables to the project manager
- Employing strategic thinking and problem-solving skills to propose and implement risk mitigations
- Participating in key meetings and serving as an escalation point for communications with investigator site staff
- Collaborating with other functional leaders to coordinate delivery handoffs and meet expected study milestones
- Developing and maintaining clinical study tools and templates
- Coordinating training to the study team
- Overseeing resourcing allocations for CRAs and Central Monitors
- Ensuring quality of clinical monitoring, central monitoring, and site management deliverables
- Reviewing project oversight dashboards and other clinical trial systems
- Understanding the monitoring strategy required for the study and participating in the development of the study risk assessment plan
- Reviewing content and quality of site and central monitoring documentation
- Interacting with clients and other functional departments
- Demonstrating understanding of other functions' roles in achieving compliance and delivery
- Overseeing CRAs and Central Monitors assigned to the study
- Providing feedback to line managers on staff performance
The ideal candidate will have:
- A 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
- Preferred experience with risk-based monitoring
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills
- Good communication, presentation, and interpersonal skills
- Strong conflict resolution skills
- Demonstrated ability to apply problem-solving techniques to resolve complex issues
- Critical thinking to determine the cause and appropriate solution in the identification of issues
- Moderate travel may be required, approximately 20%