Project Specialist – RBM Focus

Syneos Health

Project Specialist executing Risk-Based Monitoring strategies within a leading biopharmaceutical solutions organization. Collaborating with teams to analyze data trends and enhance monitoring approaches.

Posted 7/30/2026full-timeRemote • 🇪🇺 Anywhere in EuropeMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in executing Risk-Based Monitoring strategies while ensuring compliance with regulatory requirements and maintaining data integrity. Proficient in analyzing clinical data, managing Key Risk Indicators, and collaborating with cross-functional teams to enhance study conduct.

Highest-signal resume keywords

Risk-Based MonitoringClinical Trial ProcessesKey Risk Indicators (KRIs)Regulatory ComplianceData Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchClinical OperationsMonitoringPerformance MetricsQuality Tolerance Limits (QTLs)Data Quality Assessments (DQAs)GCPAnalytical SkillsProblem-Solving

Soft Skills

Stakeholder ManagementCommunicationCross-Functional Collaboration

Industry Keywords

Life SciencesPharmacyNursingAdaptive Monitoring StrategiesPatient Safety

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Execute study-specific Risk-Based Monitoring strategies in alignment with regulatory requirements and internal quality standards
Analyze clinical and operational data to identify trends, risks, and potential issues impacting study conduct
Manage Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Data Quality Assessments (DQAs)
Generate, evaluate, and communicate risk signals at the site, country, and study levels
Collaborate with monitoring and study teams to define and implement corrective and preventive actions
Escalate significant risks and track mitigation activities through to resolution
Support the development and continuous improvement of adaptive monitoring strategies
Coordinate monitoring activities based on study risk profile and operational priorities
Contribute to maintaining high standards of patient safety, data integrity, and regulatory compliance

Requirements

What you’ll need

Degree in Life Sciences, Pharmacy, Nursing, or a related field
Experience in clinical research, clinical operations, monitoring, or risk-based monitoring
Strong understanding of clinical trial processes, GCP, and regulatory requirements
Experience working with clinical trial data and performance metrics
Knowledge of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and centralized monitoring methodologies is highly desirable
Strong analytical and problem-solving skills
Excellent stakeholder management and communication abilities
Ability to work effectively in a cross-functional and global environment

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program