Clinical Trial Lead - Full-Service Delivery

Syneos Health/ inVentiv Health Commercial LLC; Providence (RI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Company car

Health benefits

401k

Job summary

Syneos Health is seeking a Clinical Trial Manager for our Providence, RI office to oversee site management, clinical monitoring, and central monitoring with a focus on patient safety, data integrity, and regulatory compliance. You will coordinate with CRAs, CeMs, data management, and functional leads to meet site activation, recruitment, and database lock milestones, while managing budgets and timelines.

This role requires leadership, problem solving, and strong communication in an international

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
• Moderate travel may be required, approximately 20%

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 contractual obligations and parameters.
• Uses operational data to identify risks to clinical trial management deliverables and escalate to the project manager as needed.
• Participates and presents in key meetings such as Kick Off Meeting.

Skills

Leadership

Project management

Risk management

Communication

GCP knowledge

Education

Bachelor's degree or RN in related field

Tools

CTMS

Job description

Syneos Health is seeking a Clinical Trial Manager for our Providence, RI office to oversee site management, clinical monitoring, and central monitoring with a focus on patient safety, data integrity, and regulatory compliance. You will coordinate with CRAs, CeMs, data management, and functional leads to meet site activation, recruitment, and database lock milestones, while managing budgets and timelines.

This role requires leadership, problem solving, and strong communication in an international