Syneos Health is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by translating clinical and medical insights into real-world outcomes. We are currently looking for a Project Specialist with a focus on Risk-Based Monitoring to join our team and contribute to our mission of shortening the distance from lab to life.
Key responsibilities
- 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, Quality Tolerance Limits, and Data Quality Assessments.
- 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.
Requirements
- Degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Proven experience in clinical research, clinical operations, or risk-based monitoring.
- Strong understanding of clinical trial processes, GCP, and regulatory requirements.
- Experience working with clinical trial data and performance metrics.
- Excellent analytical, problem-solving, and stakeholder management skills.
What we offer
- Opportunities for career development and progression within a global organization.
- Supportive and engaged line management with access to technical and therapeutic training.
- A commitment to a Total Self culture where diversity of thought and background is valued.
- Participation in a comprehensive total rewards program designed to support our employees.