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

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.

- 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

- 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

- 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

- 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

- 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

- 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

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

- Central Monitoring professional with significant strategic ownership

While expertise in every platform is not required, candidates should understand:

- Advanced Microsoft Excel skills, including pivot tables, filtering, sorting, and data analysis

- Familiarity with RACT tools and risk assessment frameworks

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

- Strategic thinkers who can balance quality, risk, budget, and operational realities

- Confident communicators who can influence without direct authority

- 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

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.