RBQM Program Lead - Risk-Based Quality Management

CTI Clinical Trial and Consulting Services; Lisboa; Híbrido; EUR 40 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work from home opportunities

Health benefits

Vacation packages

Paid parental leave

Resumo da oferta

CTI Clinical Trial and Consulting Services seeks an RBQM Coordinator to support the execution and governance of RBQM across our clinical trial portfolio. You will coordinate IQRMP activities, assist in RBQM-related protocols, and partner with cross-functional teams to ensure risk oversight and documentation discipline.

This entry to mid-level role emphasizes operational execution under guidance from RBQM leadership, Clinical Project Management, and Quality Assurance.

Qualificações

• Bachelor’s degree in health, life sciences, or related field.
• At least 2 years of experience in clinical research, data management, monitoring, quality, or similar role in a CRO, pharmaceutical, or healthcare setting.
• Basic understanding of clinical trial operations and Good Clinical Practice (GCP).
• Experience reviewing clinical data, reports, or study metrics preferred.
• Experience with RBQM concepts, including KRIs, risk assessments, or centralized monitoring.
• Familiarity with ICH E6(R2/R3) guidelines.
• Experience working with clinical trial systems (e.g., EDC, RBQM tools such as CluePoints or Medidata).
• Prior experience supporting risk review processes, data review, or quality oversight activities.

Responsabilidades

• Coordinate development and maintenance of Integrated Quality and Risk Management Plans (IQRMPs).
• Support and coordinate RACT, RMP, and IDRP activities, including protocol review and assessment.
• Facilitate cross-functional risk review meetings and ensure action items are tracked to completion.
• Maintain RBQM documentation, trackers, logs, templates, and SharePoint resources.
• Coordinate RBQM trial specific activities and ensure trial team accountability.
• Support routine centralized monitoring (KRI/QTL review) activities and risk review preparation and meetings.
• Partner with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other functional teams to support RBQM execution.
• Assist the Director, RBQM with strategic, operational, and client-facing initiatives.
• Utilize RBQM platforms and systems (e.g., BI RBQM tools, CluePoints, Medidata) to support monitoring and documentation activities.
• Contribute to process improvement initiatives related to RBQM execution, tools, and documentation.

Conhecimentos

RBQM concepts

KRIs & risk assessments

Centralized monitoring

Cross-functional collaboration

Clinical research

GCP familiarit y

EDC/RBQM tools (CluePoints, Medidata)

Formação académica

Bachelor's degree in health or life sciences

Ferramentas

CluePoints

Medidata

EDC systems

Descrição da oferta de emprego

CTI Clinical Trial and Consulting Services seeks an RBQM Coordinator to support the execution and governance of RBQM across our clinical trial portfolio. You will coordinate IQRMP activities, assist in RBQM-related protocols, and partner with cross-functional teams to ensure risk oversight and documentation discipline.

This entry to mid-level role emphasizes operational execution under guidance from RBQM leadership, Clinical Project Management, and Quality Assurance.