Senior Central Risk Manager, RBQM

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

🎲 Risk

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Provide expert guidance, training, and support on RBQM in clinical trials • Advise study teams throughout risk management activities and promote cross-functional collaboration • Contribute to central monitoring tools, Quality Tolerance Limits, risks, thresholds, mitigations, and performance indicators • Participate in determining monitoring strategies and mitigation plans, including authoring the Central Monitoring Plan • Facilitate cross-functional risk review meetings and interpret and triage risk signals • Oversee resolution, escalation, and documentation of risk signals and issues • Support development and implementation of central monitoring data analytical tools • Set up and test study-level central monitoring analytics • Map, manage, and design RBQM dataflows across clinical and operational databases • Review central monitoring analytics, investigate signals and actions, and follow up on resolutions • Identify anomalies and monitor trends indicating systematic errors and potential study, site, country, or study issues • Support inspection-readiness and participate in audits and regulatory inspections as an RBQM point of contact • Serve as Subject Matter Expert and Process Owner for assigned areas, processes, and technologies • Develop, enhance, and implement RBQM processes, systems, templates, tools, and training materials • Manage RACT libraries across programs and therapeutic areas • Lead or contribute to cross-functional committees, projects, and continuous-improvement workstreams • Develop and analyze RBQM performance metrics • Champion change initiatives, innovation, best practices, and modern ways of working • Build and maintain partnerships with service providers • Represent the Sponsor in industry-wide collaborations and share best practices

🎯 Requirements

• 8-10 years in clinical research • 3 years of RBQM or Central monitoring experience • Expertise in RBQM strategies, processes, tools, and implementation • Expertise in 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 • 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 cross-cultural competency and global collaboration experience • Thorough knowledge of national and global regulations and guidelines governing clinical research • Deep understanding of Phase I-IV clinical studies, clinical operations, and cross-functional study team roles • Advanced expertise in RBQM, including risk-based monitoring, central monitoring methodologies, quality-by-design principles, risk and issue management, and root cause analyses • Outstanding knowledge of RBQM-related IT systems and data flows across clinical and operational applications and databases • High aptitude for data analytics and deep understanding of statistical concepts • Ability to travel as needed • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time