Senior Clinical Study Manager

Join Syneos Health, a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We focus on translating clinical, medical affairs, and commercial insights into outcomes that tackle modern market realities. Our Clinical Development model places customers and patients at the center of our operations. We are constantly innovating to simplify our processes, making Syneos Health both an efficient partner for clients and a rewarding workplace for our employees. In whatever capacity you join us—whether through a Functional Service Provider partnership or a Full-Service environment—you will collaborate with passionate problem solvers and be part of a team dedicated to transforming lives through accelerated therapy delivery. Why Choose Syneos Health? We are committed to your professional growth through career advancement opportunities, supportive management, comprehensive training, peer recognition, and an attractive rewards program. Our culture embraces authenticity and unity, fostering a workplace where everyone can thrive. We believe in building an inclusive company that values diverse thoughts, backgrounds, cultures, and perspectives to create an environment where all employees feel a sense of belonging. Key Responsibilities: Oversee site management, clinical monitoring, and central monitoring deliverables with an emphasis on patient safety, compliance with protocols, GCP, and regulatory standards. Ensure the clinical project team is aware of contractual obligations and parameters, using operational data to identify risks and escalate issues related to timelines, quality, and budget. Utilize strategic thinking to propose and implement risk mitigations, and participate in important meetings, including the Kick Off Meeting. Act as a point of contact for investigator site staff, interacting directly as needed, including site visits or conflict resolution. Collaborate with functional leaders in areas like Study Start Up, Patient Recruitment, and Data Management to coordinate project milestones. Develop and maintain clinical study tools, including the Clinical Monitoring Plan, ensuring CTMS and other systems are functional and accessible for the team. Provide training on protocol specifics and clinical guidelines to the study team, ensuring a thorough understanding of project requirements. Manage resource allocations for CRAs and Central Monitors, identifying quality and delivery risks as they arise. Oversee various clinical trial systems to ensure accurate site and patient activities, as well as compliance with study plans. Review monitoring documentation to ensure quality and compliance, making necessary revisions as required. Interact with clients and other departments, providing updates on clinical deliverables and identifying solutions to challenges in protocol execution. Support continuous inspection readiness for clinical trial management, working alongside various functions to maintain compliance with relevant regulations. Identify performance strengths and development areas for team members to enhance overall project delivery and quality. Coach and mentor Clinical Trial Managers, especially on complex trials or a portfolio of projects. Qualifications: Bachelor's degree or RN in a related field or an equivalent combination of education and relevant experience. Proven track record of leading teams to meet project milestones in an international context. Expertise in site management and monitoring, with a background in risk-based monitoring. Understanding of clinical trial financial principles and budget management. Knowledge of Good Clinical Practice, ICH Guidelines, and other regulatory requirements. Proficient computer skills and strong conflict resolution abilities. Ability to apply critical thinking and problem-solving to complex issues. Willingness to travel approximately 20% as needed. We are constantly on the lookout for exceptional talent. This listing is for an anticipated opportunity rather than a currently available role, but expressing interest will enter you into our talent pipeline for future consideration. At Syneos Health, we provide an enriching environment where our people can flourish, supporting their development and career advancement. The benefits for this position may include a company vehicle or allowance, health benefits (medical, dental, and vision), 401k matching, participation in an Employee Stock Purchase Plan, commissions or bonuses based on performance, and flexible paid time off. Note that eligibility for certain benefits may vary based on your location. About Syneos Health: In the past five years, we have collaborated with 94% of all novel FDA-approved drugs, 95% of EMA authorized products, and conducted over 200 studies across 73,000 sites, serving more than 675,000 trial patients. At Syneos Health, every role matters. You'll have the chance to take initiative and contribute to our mission in a dynamic environment. Learn more about us and our impact. Tasks and responsibilities outlined above may evolve, and the company reserves the right to assign additional duties as needed, with equivalent experience and skills considered. This job description does not constitute an employment contract.

Created: 2026-03-06