Hybrid RBQM Operations Manager – Clinical Trials

Ctifacts; Lisboa; Híbrido; EUR 28 000 - 48 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work from home opportunities

Health benefits and vacation packages

Paid parental leave

Resumo da oferta

CTI Clinical Trial and Consulting Services is seeking an RBQM Coordinator to drive execution and governance of the RBQM framework across the clinical trial portfolio. Under RBQM leadership, you will support risk management processes, help identify CtQ, coordinate RACT/RMP/IDRP activities, and maintain RBQM documents and follow-up accountability.

This entry-to-mid level role focuses on operational execution, working with Clinical Project Management, Data Management, Quality, Medical Monitoring,

Qualificações

• Bachelor’s degree in health or life sciences or equivalent
• At least 2 years in clinical research, data management, monitoring, or quality
• Basic understanding of clinical trial operations and GCP
• Experience with RBQM concepts and centralized monitoring
• Familiarity with ICH E6(R2/R3) guidelines
• Experience with clinical trial systems (EDC, RBQM tools)

Responsabilidades

• Coordinate development and maintenance of Integrated Quality and Risk Management Plans
• Support RBQM activities including protocol review and assessment
• Facilitate cross-functional risk review meetings and track actions
• Maintain RBQM documentation, trackers, logs, templates, and SharePoint resources
• Coordinate RBQM trial-specific activities and accountability
• Support centralized monitoring activities and risk review preparation
• Collaborate with Clinical Project Management and other teams to RBQM execution
• Utilize RBQM platforms and systems to support monitoring and documentation
• Contribute to RBQM process improvements related to tools and documentation

Conhecimentos

RBQM concepts

Risk assessments

Centralized monitoring

Cross-functional collaboration

Data management

Formação académica

Bachelor’s degree in health or life sciences

Ferramentas

CluePoints

Medidata

BI RBQM tools

Descrição da oferta de emprego

CTI Clinical Trial and Consulting Services is seeking an RBQM Coordinator to drive execution and governance of the RBQM framework across the clinical trial portfolio. Under RBQM leadership, you will support risk management processes, help identify CtQ, coordinate RACT/RMP/IDRP activities, and maintain RBQM documents and follow-up accountability.

This entry-to-mid level role focuses on operational execution, working with Clinical Project Management, Data Management, Quality, Medical Monitoring,