Description

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 – Philippines

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.

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.

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.

Summary

The Central Risk Manager (CRM ) serves as the subject matter expert for protocol execution risk management, risk-based monitoring (RBM) strategy and centralized monitoring within the project team. The CRM is accountable for drafting the initial RBM strategy, working with the cross-functional teams to assess protocol execution risks and adapt the cross-functional RBM strategy.