Manager, Risk Based Quality Management
New
J
JobgetherClinical Research
USFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- At least 2 years of experience in clinical research, data management, clinical monitoring, quality, or a related function
- Required Skills
- GCPSharePointData management
Requirements
- Bachelor’s degree in health sciences, life sciences, or a related discipline, or an equivalent combination of education and relevant experience.
- At least 2 years of experience in clinical research, data management, clinical monitoring, quality, or a related function within a CRO, pharmaceutical, healthcare, or similar environment.
- Basic understanding of clinical trial operations and Good Clinical Practice (GCP) principles.
- Familiarity with risk-based quality management concepts, including Key Risk Indicators (KRIs), risk assessments, and centralized monitoring.
- Familiarity with ICH E6(R2/R3) guidelines and their application to clinical research quality.
- Experience reviewing clinical data, reports, study metrics, or other information used to assess trial quality.
- Experience with clinical trial systems such as EDC platforms and RBQM technologies such as CluePoints or Medidata.
- Prior experience supporting risk review processes, data review, quality oversight, or related clinical trial governance activities.
- Strong organizational and coordination skills, with the ability to manage documentation, follow-ups, timelines, and multiple stakeholders.
- Effective communication and collaboration skills, with the ability to work across multidisciplinary clinical research teams.
- Analytical and detail-oriented approach with the ability to identify potential risks and support continuous improvement.
Responsibilities
- Coordinate the development, maintenance, and operational execution of Integrated Quality and Risk Management Plans (IQRMPs) across clinical studies.
- Support RACT, Risk Management Plan (RMP), and Issue Detection and Resolution Plan (IDRP) activities, including protocol review and risk assessment.
- Facilitate cross-functional risk review meetings, document outcomes, and track action items through to completion.
- Maintain RBQM documentation, trackers, logs, templates, SharePoint resources, and other governance materials.
- Coordinate study-specific RBQM activities and promote accountability across clinical trial teams.
- Support routine centralized monitoring activities, including KRI and QTL review, preparation of risk reviews, and follow-up discussions.
- Collaborate with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other functional teams.
- Use RBQM platforms and clinical trial systems, including business intelligence tools, CluePoints, Medidata, and related technologies.
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