Remote Global Clinical Trial Manager II

Syneos Health; España; On-site; PHP 5,084,000 - 7,988,000; Full time

Job summary

Syneos Health is seeking a Global Clinical Trial Manager II to oversee site management, clinical and central monitoring with a focus on patient safety and data integrity. The role involves coordinating with CRAs, central monitors, and study teams across international sites, managing risks, budgets, and timelines.

The position emphasizes leadership, strategic risk mitigation, and collaboration with cross-functional teams to ensure protocol adherence and regulatory compliance.

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
• Good communication, presentation and interpersonal skills among project team and with sites
• 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. This may include patient recruitment, investigator payments or other related activities.
• 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 (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings such as Kick Off Meeting.
• 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 to coordinate delivery handoffs and meet study milestones such as site activation targets, enrollment targets and database lock timelines.
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
• Oversees development and maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team.
• Coordinates initial and ongoing training to the study team regarding protocol specifics, CRF completion, dashboards, SOPs, data plans and timelines.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and team conduct, and identifies risks to delivery or quality.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintains visibility via approved systems.
• Reviews project oversight dashboards and clinical trial systems to oversee site and patient activities and data updates.
• Understands monitoring strategy and participates in development of the study risk assessment plan.
• Reviews site and central monitoring documentation to ensure they reflect management activities and convey risks to compliance, trial conduct, patient safety or data integrity.
• Interacts with the client and other functions and provides status updates on deliverables and risks.
• Demonstrates understanding of other functions' roles and supports Inspection Readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors and supports corrective actions and data cut/lock deadlines.
• Provides feedback to line managers on staff performance and may be assigned to larger trials.

Skills

Leadership

Cross-functional collaboration

Risk management

Education

Bachelor’s degree or RN

Job description

Syneos Health is seeking a Global Clinical Trial Manager II to oversee site management, clinical and central monitoring with a focus on patient safety and data integrity. The role involves coordinating with CRAs, central monitors, and study teams across international sites, managing risks, budgets, and timelines.

The position emphasizes leadership, strategic risk mitigation, and collaboration with cross-functional teams to ensure protocol adherence and regulatory compliance.