Clinical Trial Manager – Full-Service Trials

Syneos Health/ inVentiv Health Commercial LLC; Honolulu (HI); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits

401k match

Stock Purchase Plan

Bonus eligibility

Flexible PTO

Job summary

Syneos Health is seeking a Clinical Trial Manager to oversee site management, monitoring, and central monitoring with a focus on patient safety, data integrity and regulatory compliance from startup through closeout.

The role collaborates with CRAs, CMS, data management and study teams to meet milestones like site activation, enrollment and database lock. Bachelor’s degree or RN and trial management experience are required, with travel up to 20%.

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.
• Strong conflict resolution skills.
• Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.

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.
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of contractual obligations and parameters.
• Uses data, metrics and reports to identify risks to deliverables; escalates to the project manager when needed.
• Employs strategic thinking to propose and implement risk mitigations and participates in key meetings.
• Serves as an escalation point for communications with investigator site staff and may interact with principal investigators.
• Collaborates with Study Start Up, Patient Recruitment and Data Management to coordinate handoffs and milestones.
• Develops and maintains study tools and templates; ensures CTMS and dashboards are available and tested.
• Coordinates training to the study team on protocol specifics, CRF completion, dashboards and SOPs.
• Oversees resourcing allocations for CRAs, Central Monitors, and study team conduct; manages progress visibility.
• Reviews monitoring dashboards and CTMS/EDC/ePROs/TMF for timely data and plan execution.
• Understands monitoring strategy; ensures compliance and delivery according to CMP/SMP and risk plans.
• Reviews site/central monitoring documentation to reflect risks to protocol, safety or data integrity.
• Interacts with client and other functions; provides updates and solutions.
• Supports Inspection Readiness and ensures QA alignment where needed.
• Oversees CRAs and Central Monitors; develops corrective actions and supports data cut/lock timelines.
• Provides feedback to line managers on performance; may coordinate CTMs across a portfolio and mentor others.

Education

Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience

Job description

Syneos Health is seeking a Clinical Trial Manager to oversee site management, monitoring, and central monitoring with a focus on patient safety, data integrity and regulatory compliance from startup through closeout.

The role collaborates with CRAs, CMS, data management and study teams to meet milestones like site activation, enrollment and database lock. Bachelor’s degree or RN and trial management experience are required, with travel up to 20%.