Clinical Trial Manager: Site & Risk Oversight Leader

Syneos Health/ inVentiv Health Commercial LLC; Baltimore (MD); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits

401k with company match

Stock Purchase Plan

Paid time off (PTO)

Job summary

Syneos Health is seeking a Clinical Trial Manager to oversee site management, clinical monitoring, and data integrity across trials in a fast-paced, regulated environment. You will coordinate cross-functional teams, manage risks, and ensure adherence to protocol, GCP, and regulatory requirements.

The role requires leadership, international collaboration, and the ability to drive milestones, with exposure to CTMS, EDC and related study systems.

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 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.

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.
• Employs strategic thinking and problem-solving to propose and implement risk mitigations.
• 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 delivery handoffs and milestones.
• Develops and maintains clinical study tools and templates, including the Clinical Monitoring Plan.
• Coordinates initial and ongoing training to the study team regarding protocol, CRF, dashboards, SOPs, data plans and timelines.
• Oversees resourcing allocations for CRAs and Central Monitors and tracks progress via approved tools.

Skills

Leadership

International environment

Conflict resolution

Problem solving

Budget management

Computer skills

Travel readiness

Education

Bachelor's degree or RN

Tools

CTMS

EDC

eDiary

ePROs

TMF

IVRS/IWRS

Dashboards

Job description

Syneos Health is seeking a Clinical Trial Manager to oversee site management, clinical monitoring, and data integrity across trials in a fast-paced, regulated environment. You will coordinate cross-functional teams, manage risks, and ensure adherence to protocol, GCP, and regulatory requirements.

The role requires leadership, international collaboration, and the ability to drive milestones, with exposure to CTMS, EDC and related study systems.