[Hiring] CTM, FSP BU @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.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content, ensuring the clinical project team is aware of contractual obligations.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates risks to clinical trial management deliverables (timeline, quality and budget) to the project manager.
• 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.
• 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 regarding protocol specificities and clinical plans.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables.
• 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 the content and quality of site and central monitoring documentation to ensure compliance.
• Interacts with the client and other functional departments related to clinical monitoring activities.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol.
• Oversees CRAs and Central Monitors assigned to the study and assesses study-specific process compliance.
• 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.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.