Central Risk Manager

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

We are 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. We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.

Job Responsibilities:

• Serve as a recognized RBQM and Centralized Monitoring subject matter expert across global clinical programs.
• Influence study quality strategy from protocol review through study execution.
• Partner directly with sponsors and senior stakeholders to develop and execute monitoring approaches.
• Shape risk-based monitoring strategies that impact study quality, efficiency, resource utilization, and patient safety.
• Operate in a highly consultative role with significant visibility and organizational influence.
• Leverage advanced analytics and centralized monitoring methodologies to drive proactive risk identification and mitigation.
• Collaborate with experienced cross‑functional clinical research professionals.
• Work at the forefront of evolving RBQM methodologies, technology platforms, data analytics, and emerging innovations within clinical research.
• Opportunity to mentor colleagues and help drive continuous improvement across programs and teams.

What You Will Own:

• Review study protocols to identify critical data, processes, risks, and quality considerations.
• Lead and facilitate protocol execution risk assessments across cross-functional teams.
• Develop and refine Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM) strategies.
• Draft and support Risk Assessment Categorization Tools (RACTs) and associated risk management documentation.
• Identify risk mitigation plans and ensure appropriate oversight throughout study execution.

Analytics & Data-Driven Decision Making:

• Utilize centralized monitoring technologies and analytics platforms to support risk identification and oversight.
• Leverage data-driven insights to guide monitoring strategy decisions.
• Ensure monitoring approaches remain aligned with evolving study risks and operational realities.
• Recommend strategic adjustments to monitoring activities, resource allocation, and oversight plans when necessary.
• Evaluate centralized statistical monitoring outputs and recommend appropriate actions.
• Support adoption of innovative technologies and emerging approaches to risk management.

Sponsor & Stakeholder Partnership:

• Present monitoring strategies, risk assessments, and recommendations to internal stakeholders and sponsors.
• Clearly communicate complex risk concepts to diverse audiences.
• Build credibility as a trusted advisor capable of influencing strategic decisions.
• Facilitate collaborative discussions focused on quality, compliance, efficiency, and patient safety.

Cross-Functional Leadership & Oversight:

• Collaborate with Clinical Operations, Data Management, Medical Monitoring, Safety, Quality, and other functional teams.
• Provide guidance and mentorship regarding RBQM methodologies and monitoring strategies.
• Ensure consistency across studies, programs, therapeutic areas, and sponsor engagements.
• Escalate risks appropriately and proactively when quality, timeline, budget, or delivery concerns arise.
• Support business development activities including strategy discussions, proposal development, and budget input as needed.

Required Qualifications:

• Bachelor's degree, RN, or equivalent combination of education, training, and clinical research experience.
• Significant experience within clinical research, CRO, biotechnology, or pharmaceutical environments.
• Deep expertise in Risk-Based Quality Management (RBQM) methodologies.
• Strong experience with Risk-Based Monitoring (RBM) strategies and implementation.
• Central Monitoring experience or exposure, including methodologies, technologies, and operational execution.
• Demonstrated experience conducting study-level risk assessments and developing monitoring strategies.
• Strong understanding of ICH‑GCP and applicable regulatory requirements.
• Excellent verbal and written communication skills with strong English proficiency.
• Proven ability to present complex concepts clearly and persuasively.
• Strong stakeholder management, negotiation, and influencing capabilities.
• Exceptional critical thinking, analytical, and problem-solving skills.
• Ability to work independently within fast-paced, evolving environments.

Preferred Backgrounds:

• Risk Manager
• RBQM Lead
• Clinical Trial Manager (CTM)
• Central Monitoring Lead
• Project Lead / Clinical Project Manager
• Data Management Lead
• Central Monitoring professional with significant strategic ownership.

Technical Expertise:

• Central Monitoring & Analytics Platforms: CluePoints, Spotfire, Tableau, Power BI, and other centralized monitoring and analytics technologies.
• Data Analytics & Visualization: Data visualization techniques, trend analysis, outlier detection, data integrity assessment, statistical monitoring concepts, risk signal detection methodologies, and advanced Microsoft Excel skills.

Success in this Role:

• Strategic thinkers who can balance quality, risk, budget, and operational realities.
• Confident communicators who can influence without direct authority.
• Self-motivated professionals who thrive with autonomy.
• Critical thinkers who challenge assumptions and identify better solutions.
• Adaptable leaders comfortable navigating ambiguity and change.
• Collaborative team players who support colleagues and contribute positively to team culture.
• Curious professionals who embrace innovation and continuous learning.

Team Culture:

This is a highly collaborative, fast‑paced team that values partnership, transparency, accountability, and continuous improvement. Team members are expected to communicate openly, support one another, share knowledge, and work together to solve complex challenges. While strong technical expertise is essential, success in this role also requires a positive attitude, adaptability, and a willingness to share a one‑team mentality.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.