Remote Clinical Trial Manager: Site & Data Oversight

Syneos Health, Inc.; Kansas; Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (medical, dental, and视

401k with company match

Employee Stock Purchase Plan

Bonus/Commission eligibility

Flexible PTO

Job summary

Syneos Health, Inc. seeks an experienced Clinical Trial Manager to oversee site management, monitoring, and data integrity across studies.

You will coordinate cross-functional teams, manage risks, and ensure compliance with protocol, GCP, and regulatory requirements in a global setting. The role involves developing monitoring plans, training the study team, and optimizing study delivery timelines and budgets while collaborating with investigators and sponsors.

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.
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations and parameters.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet milestones.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
• Coordinates initial and ongoing training to the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor SOPs, and data timelines.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
• Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities, and ensure data reflects timely execution.
• Interacts with the client and other functional departments related to monitoring and site management activities and deliverables.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and regulations.
• Oversees CRAs and Central Monitors and develops corrective action plans.
• May coach and mentor CTMs regarding functional clinical delivery.

Skills

Leadership & team alignment

International experience

Regulatory knowledge

Problem solving

Conflict resolution

Critical thinking

Project risk management

Computer proficiency

Communication with investigators

Monitoring strategy

Travel flexibility

Education

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

Job description

Syneos Health, Inc. seeks an experienced Clinical Trial Manager to oversee site management, monitoring, and data integrity across studies.

You will coordinate cross-functional teams, manage risks, and ensure compliance with protocol, GCP, and regulatory requirements in a global setting. The role involves developing monitoring plans, training the study team, and optimizing study delivery timelines and budgets while collaborating with investigators and sponsors.