[Hiring] CTM II @Syneos Health

Role Description

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 and investigator payments.
• Identifies critical data and process, protocol execution risks and risk mitigations related to the completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews study scope of work, budget and protocol content to ensure clinical project team awareness of contractual obligations.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates risks to project manager regarding clinical trial management deliverables (timeline, quality, budget) and out-of-scope activities.
• Employs strategic thinking and problem-solving skills 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 with principal investigators or other site staff members.
• Collaborates with functional leaders (Study Start Up, Patient Recruitment, Data Management) to coordinate delivery handoffs and meet study milestones.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
• Coordinates initial and ongoing training to the study team regarding protocol specifics, CRF completion, dashboards, SOPs, clinical plans and timelines.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team conduct.
• Ensures quality of clinical monitoring, central monitoring and site management deliverables within a project.
• Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities.
• Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan.
• Reviews content and quality of site and central monitoring documentation to ensure compliance and data integrity.
• Interacts with clients and other functional departments related to clinical monitoring and site management activities.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
• Oversees CRAs and Central Monitors, assesses study-specific process and training compliance, and identifies emerging risks.
• Provides feedback to line managers on staff performance, including strengths and areas for development.

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 to resolve complex issues.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20%.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.
• Collaborative environment with smart colleagues from across the world.