Weitere Details
Freelance Consultant Principal, Evidence Generation Data Management (m/f/x) (EN)
[17121]
Clinical Data Management, SAS programming, Biostatistik
Freelance Consultant Principal, Evidence Generation Data Management (m/f/x) Travel activities: Seldom, if so in EU Workload: 40 hours / week Remote option: 100% possible Start: 15.03.2026 End: 30.09.2026 Key Responsibilities: ·Act in a consulting and independent capacity in overseeing the operational development and implementation of Risk-Based Quality Management (RBQM) components tailored for risk assessment, mitigation, and monitoring within non-interventional studies ·Provide technical expertise in the establishment and operations of a comprehensive Key Risk Indicator (KRI) system, incorporating dashboards, a centralized statistical monitoring platform, and an audit trail review module, aligning with the team in whether internal resources or external solutions must be used ·Provide assessment in the design, pilot, and implementation of centralized monitoring processes to enhance study oversight and data quality Requirements: ·Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biostatistics, Data Science, Public Health, or a related discipline preferred ·Minimum of 7 years’ experience in clinical research, ideally within centralized monitoring, data management, biostatistics, or Clinical Research Associate (CRA) roles ·In-depth knowledge of risk-based quality management consistent with current industry standards and best practices ·Fluency in English, german is an advantage but not required ·Proven expertise in: ·Developing and introducing RBQM components for centralized monitoring ·Conducting and providing technical expertise in non-interventional studies. ·Risk assessment methodologies, monitoring strategies, and mitigation techniques. ·Defining, developing, and deploying Key Risk Indicators (KRIs). ·Executing and overseeing/leading centralized monitoring activities with hands-on experience using related systems and tools. ·Applying data-driven oversight across clinical trials, including identification of risk signals and quality issues via statistical review, trend analysis, and continuous data surveillance. ·providing expert evaluation on early detection of data anomalies, protocol deviations, safety signals, and operational risks, facilitating targeted interventions, expedited processes, and adherence to GCP and RBM principles ·Highly organized and detail-oriented with the ability to work independently while maintaining strong alignment within cross-functional teams ·Demonstrates flexibility, effectively managing priorities under pressure ·Strong communication abilities with proven success working in diverse, international environments
- Act in a consulting and independent capacity in overseeing the operational development and implementation of Risk-Based Quality Management (RBQM) components tailored for risk assessment, mitigation, and monitoring within non-interventional studies
- Provide technical expertise in the establishment and operations of a comprehensive Key Risk Indicator (KRI) system, incorporating dashboards, a centralized statistical monitoring platform, and an audit trail review module, aligning with the team in whether internal resources or external solutions must be used
- Provide assessment in the design, pilot, and implementation of centralized monitoring processes to enhance study oversight and data quality
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biostatistics, Data Science, Public Health, or a related discipline preferred
- Minimum of 7 years’ experience in clinical research, ideally within centralized monitoring, data management, biostatistics, or Clinical Research Associate (CRA) roles
- In-depth knowledge of risk-based quality management consistent with current industry standards and best practices
- Fluency in English, german is an advantage but not required
- Proven expertise in:
- Developing and introducing RBQM components for centralized monitoring
- Conducting and providing technical expertise in non-interventional studies.
- Risk assessment methodologies, monitoring strategies, and mitigation techniques.
- Defining, developing, and deploying Key Risk Indicators (KRIs).
- Executing and overseeing/leading centralized monitoring activities with hands-on experience using related systems and tools.
- Applying data-driven oversight across clinical trials, including identification of risk signals and quality issues via statistical review, trend analysis, and continuous data surveillance.
- providing expert evaluation on early detection of data anomalies, protocol deviations, safety signals, and operational risks, facilitating targeted interventions, expedited processes, and adherence to GCP and RBM principles
- Highly organized and detail-oriented with the ability to work independently while maintaining strong alignment within cross-functional teams
- Demonstrates flexibility, effectively managing priorities under pressure
- Strong communication abilities with proven success working in diverse, international environments
Iryna Pryval