Project Specialist – RBM Focus

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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

• 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

• 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

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