Clinical Trial Leader: Drive Study Delivery & Safety

Syneos Health/ inVentiv Health Commercial LLC; Plano (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (medical/dental/vision

401k

Stock Purchase Plan

Bonus based on performance

Paid time off

Job summary

Syneos Health in Plano, TX is seeking a Clinical Trial Manager to oversee site management, monitoring activities and data integrity across trials. You will coordinate CRO, sites and internal teams to ensure timelines, budgets and quality objectives are met.

Strong leadership, communication and risk-based monitoring experience are required. The role involves collaboration with Study Start Up, Data Management and Recruitment teams, plus ongoing training and tool maintenance to enable efficient

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 achievement of project milestones.
• Ability to work in an international environment.
• Expertise in site management and monitoring (clinical or central).
• Knowledge of risk-based monitoring.
• Understanding of clinical trial management financial principles and budget management.
• Good computer skills and strong conflict resolution.
• Ability to apply problem solving and risk management techniques.

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 scope of work, budget and protocol content; ensures team awareness of contractual obligations and parameters.
• Employs strategic thinking to propose risk mitigations and participates in key meetings.
• Acts as 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 meet milestones.
• Maintains CTMS, dashboards and systems; oversees UAT and access/audit trails.
• Coordinates training for the study team on protocol specifics, CRF completion, dashboards, SOPs and timelines.
• Oversees resourcing for CRAs and Central Monitors; identifies risks to delivery or quality.
• Reviews monitoring documentation to ensure quality and timely execution; documents revisions in CTMS.
• Interfaces with client and functional departments to provide status updates and solutions for obstacles.
• Supports Inspection Readiness and ensures adherence to CMP/SMP and risk plans.
• May coach CTMs and coordinate across a portfolio of projects.

Skills

Leadership

Project management

Cross-functional collaboration

Risk management

Problem solving

Communication

Education

Bachelor's degree or RN

Tools

CTMS

EDC

Job description

Syneos Health in Plano, TX is seeking a Clinical Trial Manager to oversee site management, monitoring activities and data integrity across trials. You will coordinate CRO, sites and internal teams to ensure timelines, budgets and quality objectives are met.

Strong leadership, communication and risk-based monitoring experience are required. The role involves collaboration with Study Start Up, Data Management and Recruitment teams, plus ongoing training and tool maintenance to enable efficient