Central Risk Manager (RBQM & Central Monitoring)

Central Risk Manager (RBQM & Central Monitoring)
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

WHO YOU ARE

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
Strong preference will be given to candidates who have operated in strategic or leadership-level roles such as:
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

Ideal candidates will have familiarity with:
Central Monitoring & Analytics Platforms
Examples include:
CluePoints

Spotfire

Tableau

Power BI

Other centralized monitoring and analytics technologies

While expertise in every platform is not required, candidates should understand:
How these tools support RBQM and centralized monitoring

Risk identification methodologies

Data review workflows

Analytics-driven decision making

Data Analytics & Visualization
Knowledge of:
Data visualization techniques

Trend analysis

Outlier detection

Data integrity assessment

Statistical monitoring concepts

Risk signal detection methodologies

Additional Technical Expertise
Advanced Microsoft Excel skills, including pivot tables, filtering, sorting, and data analysis

Understanding of quality risk management principles

Familiarity with RACT tools and risk assessment frameworks

Interest in emerging technologies, AI, and innovation within clinical research

SUCCESS IN THIS ROLE

The strongest candidates will be:
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. The team values professionals who are collaborative, proactive, and committed to both personal growth and collective success. Strong relationships, teamwork, and mutual respect are considered just as important as subject matter expertise.

If you're looking for an opportunity to influence study quality strategy, drive risk-based monitoring excellence, partner directly with sponsors, and serve as a trusted RBQM leader within a fast-paced global clinical research environment, this is the kind of role that elevates careers.

Approximate Salary Range - $121,000-$150,000

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work.

Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:
$95,000.00 - $175,700.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

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.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.