Description
Syneos Health is seeking a CTM II - Sponsor dedicated to work remotely from Argentina.
The Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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.
- May be responsible for identification of 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 the contractual obligations and parameters.
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Escalates to the project manager any risks to clinical trial management deliverables.
- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Participates and presents in key meetings.
- Serves as an escalation point for communications with investigator site staff.
- Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
- Responsible for development and ongoing maintenance of clinical study tools and templates.
- Coordinates initial and ongoing training to the study team.
- Oversees resourcing allocations for CRAs and Central Monitors.
- Ensures quality of the clinical monitoring, central monitoring and site management deliverables.
- Reviews the project oversight dashboards and other clinical trial systems.
- Understands the monitoring strategy required for the study.
- Reviews the content and quality of site and central monitoring documentation.
- Interacts with the client and other functional departments.
- Demonstrates understanding of other functions' roles in achieving compliance and delivery.
- Oversees CRAs and Central Monitors assigned to the study.
- Provides feedback to line managers on staff performance.
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.
- 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.
- Strong conflict resolution skills.
- Demonstrated ability to apply problem solving techniques to resolve complex issues.
- Moderate travel may be required, approximately 20%.