Sr. Central Risk Manager, RBQM (North America)

Sr. Central Risk Manager, RBQM (North America)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

*This is a North America based remote role. 

*Required: 8-10 years in clinical research with 3 years of RBQM or Central monitoring experience.

RESPONSIBILITIES:

Study Risk Assessment and Central Monitoring

• Provide expert guidance, training, and support on RBQM in clinical trials, ensuring adherence to ICH GCPs, regulatory requirements, and internal processes.

• Advise study teams throughout risk management activities, fostering cross-functional collaboration, and promoting excellence in risk management. 

• Contribute to the development of new central monitoring tools to address risks and support study oversight.

• Contribute to the identification and definition of Quality Tolerance Limits, risks, thresholds, mitigations, and performance indicators.

• Participate in determining monitoring strategies and mitigation plans aligned with study and site risks, including authoring the Central Monitoring Plan.

• Facilitate cross-functional risk review meetings with study teams, collaborating in risk signal interpretation and triage, ensuring effective communication and resolution of issues.

• Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation.

• Support the development and implementation of data analytical tools used for central monitoring.

• Provide technical expertise to set up and test study-level central monitoring analytics.

• Map, manage, and design RBQM dataflows to integrate with other relevant clinical and operational databases at study, program, and enterprise level.

• Review central monitoring analytics and assist with the investigation of signals and actions, including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.

• Identify and interpret anomalies and monitor trends indicative of systematic errors and potential study, site, country, and/or study issues.

• Support inspection-readiness and participate in audits and regulatory inspections, serving as a point of contact for RBQM.

Operational Excellence

• Serve as a Subject Matter Expert and Process Owner for assigned areas, processes, and technologies.

• Contribute to the development, enhancement, and implementation of RBQM processes, systems, templates, tools, and training materials to support operational efficiency and scalability.

• Manage RACT libraries, driving consistency across programs and therapeutic areas.

• Lead or actively contribute to cross-functional committees, projects and workstreams focused on continuous improvement and innovation. 

• Develop and analyze RBQM performance metrics to assess compliance, effectiveness, and areas for optimization.

• Serve as a champion for change initiatives by fostering an innovative mindset, bridging RBQM knowledge across functions, and promoting new ideas, best practices, and modern ways of working.

• Build and maintain strong partnerships with service providers, influencing strategic relationships and ensuring high-quality deliverables.

• Represent the Sponsor in industry-wide collaborations, contributing thought leadership and sharing best practices.

Skills/Competencies

• Expertise in RBQM strategies, processes, tools, and implementation

• Expertise in the use of data analytic software, Analytical Data Visualization Tools, and MS Excel

• Proficient in R programming language

• Technical understanding of statistical analysis techniques in central monitoring

• Advanced analytical and problem-solving skills; highly attentive to detail and skilled in data analytics

• Ability to lead without authority and influence stakeholders across functions, cultures, and geographies

• Negotiation and conflict resolution skills

• Strong verbal, written, and presentation communication skills

• Fluent in English, both written and spoken

• Strong interpersonal skills and able to build and maintain strong relationships

• Strong cross-cultural competency and global collaboration experience across multiple functional areas

• Ability to quickly absorb study design and therapeutic area knowledge; think critically to identify risks, interpret data trends, and manage issues

• Strong organizational and time management skills; able to work independently, manage competing priorities, and deliver results on time and within budget

Knowledge & Other Requirements

• Thorough knowledge of national and global regulations and guidelines governing clinical research

• Deep understanding of Phase I-IV clinical studies, clinical operations, and the roles of cross-functional study team members

• Advanced expertise in RBQM, including risk-based monitoring, central monitoring methodologies, quality-by-design principles, risk and issue management, and root causes analyses

• Outstanding knowledge of RBQM-related IT systems and data flows across clinical and operational applications and databases

• High aptitude for data analytics and a deep understanding of statistical concepts

• Ability to travel as needed

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

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:

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.

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

Provides leadership, direction and management to Central Monitoring Specialists and Risk Managers. Provides training, consultation and oversees quality related for operating activities to ensure project deliverables are met. Acts as primary point of contact for risk-based monitoring strategy and alignment both internally and externally. May liaise with other departments or business units to optimize resources as well as to harmonize central monitoring and clinical operations practices, processes and tools. Contributes to operational initiatives and continuous improvement. Participates in industry events related to risk-based management and monitoring. Responsible for acting as primary point of contact for key accounts in developing an agreed monitoring strategy across a portfolio of projects.