Central Risk Manager (RBQM & Central Monitoring) - Remote: United States or Cana

Central Risk Manager (RBQM & Central Monitoring) - Remote: United States or Canada 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.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know

Why Syneos Health

• 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.

• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Central Risk Manager (RBQM & Central Monitoring)

Remote – United States or Canada

Are you an RBQM and Centralized Monitoring expert who thrives at the intersection of clinical quality, risk management, data analytics, and RBM strategy designs?

This is a highly visible opportunity for an experienced Central Risk Manager to serve as a subject matter expert in Risk-Based Quality Management (RBQM), Risk-Based Monitoring (RBM), and Central Monitoring across complex global clinical trials.

We're looking for a strategic thinker who can assess study protocols, identify critical risks, develop monitoring strategies, and confidently influence both internal stakeholders and sponsors. This is not a role focused solely on execution - it is a consultative subject matter expert position requiring strong business acumen, exceptional communication skills, and the ability to provide recommendations as a trusted expert.

The ideal candidate brings deep RBQM and Central Monitoring expertise, strong analytical capabilities, and the confidence to navigate complex discussions involving study quality, monitoring approaches, resource allocation, and budget considerations.

This is a remote opportunity open to candidates located in either the United States or Canada.

WHAT MAKES THIS OPPORTUNITY DIFFERENT

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

Risk-Based Quality Management & Monitoring Strategy

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

Present recommendations with confidence while managing questions, challenges, and competing viewpoints

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