Senior Clinical Trial Manager - Full-Service

Join Syneos Health, a top-tier fully-integrated life sciences services organization dedicated to accelerating customer success across the drug development and commercialization continuum. Our Clinical Solutions team is comprised of experienced professionals who understand client needs and are committed to shaping innovative solutions.

As a Senior Clinical Trial Manager, you will work in an environment where collaboration and passion for problem-solving lead to successful project outcomes. Be a part of a diverse team where your contributions truly make a difference.

Key Responsibilities:
• Oversee site management, clinical monitoring, and central monitoring, focusing on patient safety, protocol compliance, and data integrity from activation to closeout.
• Review study scope, budget, and protocol content to ensure the clinical project team understands contractual obligations.
• Utilize strategic and problem-solving skills to implement risk mitigations and present at key meetings.
• Serve as a communication liaison with investigator site staff and assist CRAs in site interactions.
• Collaborate with functional leaders for smooth coordination and achievement of study milestones such as enrollment targets and database locks.
• Develop and maintain clinical study tools and templates, ensuring systems are set up for team use.
• Provide ongoing training to the study team on protocol specifics, data plans, and guidelines.
• Oversee resource allocations for CRAs, monitor quality deliverables, and maintain visibility of project progress.
• Conduct reviews of clinical trial systems to ensure accurate data representation and compliance with project timelines.
• Develop an understanding of required monitoring strategy and maintain team awareness of the same.
• Manage site and central monitoring documentation, ensuring compliance and conveying risks effectively.
• Engage with clients and other departments, providing status updates and solutions for any protocol execution obstacles.
• Support inspection readiness and maintain accountability for compliance across trial management scope.
• Identify training compliance and emerging risks among CRAs and implement corrective action plans.
• Provide performance feedback to line managers and may mentor junior Clinical Trial Managers.
• May oversee larger trials or coordinate activities across multiple projects.

Qualifications:
• Bachelor's degree or RN in a relevant field, or equivalent experience.
• Proven leadership in aligning teams to achieve project goals.
• Experience in an international working environment.
• Expertise in site management and monitoring activities.
• Familiarity with risk-based monitoring methodologies.
• Understanding of clinical trial financial management.
• Knowledge of Good Clinical Practice, ICH Guidelines, and regulatory standards.
• Strong computer skills and conflict resolution capabilities.
• Ability to apply problem-solving techniques effectively.
• Critical thinking skills for issue identification and resolution.
• Willingness to travel moderately (approximately 20%).

At Syneos Health, we prioritize creating an environment where our people can thrive. We offer comprehensive benefits, including medical, dental, and vision coverage, 401k match, stock purchase plans, and flexible paid time off. Join us to make a significant impact in the world of healthcare.

Over the past 5 years, we've partnered with a majority of authorities in drug development, supporting thousands of trials and patients. No matter your role, you will contribute to meaningful advancements in healthcare.