[Hiring] Clinical Trial Manager I or II @Syneos Health

Role Description

Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 through to Phase 4 clinical research studies at the organization's facilities. Responsibilities include:

• Collaborating with the principal investigator and liaising between research subjects, client teams, investigators, and clinic operations teams.
• Planning logistics and resource usage.
• Tracking study progress in alignment with project milestones, client deliverables, and budget.
• Following applicable regulations globally and by region.
• Supervising experienced support employees and/or entry individual contributors.
• Delivering operational results that have moderate impact on the immediate achievement of results for the team.
• Understanding basic management approaches such as work scheduling, prioritizing, coaching, and process execution.
• Responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
• Overseeing site interactions post-activation through site closeout, including patient recruitment and investigator payments.
• Identifying critical data and process, protocol execution risks, and risk mitigations related to the completion of the Risk Assessment and Categorization Tool (RACT).
• Reviewing study scope of work, budget, and protocol content.
• Using prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables.
• Escalating risks to the project manager regarding clinical trial management deliverables.
• Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participating and presenting in key meetings such as Kick Off Meeting.
• Collaborating with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
• Responsible for development and ongoing maintenance of clinical study tools and templates.
• Ensuring CTMS, dashboards, and other systems are set up and available for use by the clinical team.
• Coordinating initial and ongoing training to the study team regarding protocol specificities.
• Overseeing resourcing allocations for CRAs and Central Monitors.
• Ensuring quality of clinical monitoring, central monitoring, and site management deliverables.
• Reviewing project oversight dashboards and other clinical trial systems.
• Understanding the monitoring strategy required for the study.
• Reviewing the content and quality of site and central monitoring documentation.
• Interacting with the client and other functional departments related to clinical monitoring and site management activities.
• Demonstrating understanding of other functions' roles in achieving compliance and delivery.
• Overseeing CRAs and Central Monitors assigned to the study.
• Providing feedback to line managers on staff performance.

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.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20%.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.
• Collaborative environment with passionate problem solvers.