AD, Central Monitoring RBQM (US Only)

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

*This is a US remote role. Must be located in United States with no sponsorship needs to be considered for this 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

• Stay current with RBQM-related regulations, trends, and industry standards to continuously improve the RBQM framework, processes, technologies, oversight, and compliance.

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.

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.