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Risk Manager

Company: Disability Solutions
Location: Sacramento
Posted on: July 3, 2024

Job Description:

This position is responsible for facilitating Risk-Based Quality Management (RBQM) conduct on assigned trials, by leveraging knowledge of relevant regulatory requirements and Jazz processes. This position provides training and support to Clinical Trial Working Groups (CTWGs) on all aspects of risk identification, evaluation, acceptance, control and communication, from study concept to close-out on assigned Phase 1-4 trials (in-house or outsourced).Essential Functions

  • Conducts all activities of 'Risk Manager' for assigned clinical trials, per Jazz RBQM process.
  • Provides training and guidance to CTWGs on risk process.
  • At the time of Study Outline development, facilitates the identification of critical data and processes and records these within the risk tool (file or RACT (Risk Assessment Categorisation Tool) technology solution).
  • Sets up trial-specific RACT.
  • Facilitates trial risk assessment by cross-functional CTWG for assigned trials, advising on risk identification, evaluation, acceptance, control, review and communication as appropriate throughout the conduct of the trial.
  • Collaborates with appropriate trial contributors in establishment of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for critical risks as well as KRIs and thresholds for non-critical risks, advising on approach and best practice.
  • Approves initial RACT version, substantial updates and final version.
  • As applicable, liaises with vendor/CRO as early as possible to ensure cross-functional Jazz input into vendor/CRO risk assessment.
  • Coordinates establishment of trial risk-based monitoring strategy in conjunction with CTWG, Electronic Data Capture programmer and Monitoring.
  • As applicable, contributes to and oversees vendor/CRO risk management activities as defined in the Trial Oversight Plan, reporting performance/concerns to Clinical Trial Manager (CTM) and to Associate Director (AD), RBQM.
  • Facilitates review of the risk tool at the specified frequency and per triggers defined in the Trial Oversight Plan.
  • Where a critical risk is realized (QTL breached), contributes to root cause analysis, action plan development and ensures that a contemporaneous record of the QTL breach, remedial actions and outcomes is documented.
  • Develops expertise in RBQM technology solutions and tools; advises and supports CTWG members with their use.
  • Supports and promotes risk process compliance (including periodic risk review) for assigned trials, providing regular updates and issue escalation to CTM and to AD, RBQM.
  • May coordinate periodic or adhoc updates per trial or across program(s)/portfolio as required and present/interpret for key stakeholders.
  • May attend RBQM Cross-Functional Forum, as needed.
  • Champions RBQM consistency and knowledge management (Lessons Learned).
  • Maintains continuous process improvement approach.
  • Supports inspection readiness.Required Knowledge, Skills, and Abilities
    • Operational experience (minimum 5 years) in clinical trial conduct (within trial management, monitoring, data management or related field).
    • Broad understanding of clinical trial operations and ability to work collaboratively across functional areas.
    • Knowledge of RBQM from a regulatory and best-practice perspective.
    • Experience of conducting/facilitating clinical trial risk assessment and management.
    • Demonstrated capabilities in root cause analysis and effective issue resolution.
    • Strong analytical and data interpretation skills.
    • Understanding of statistical analysis techniques, visualisations and tools is helpful, but not required.
    • Ability to communicate clearly on complex topics - to train and inform.
    • Flexible and adaptable to a fast-changing environment.
    • Able to carry out responsibilities with minimal supervision.Required/Preferred Education and Licenses
      • Bachelor's degree (or equivalent), Master's degree or health data sciences degree preferred.

Keywords: Disability Solutions, Sacramento , Risk Manager, Executive , Sacramento, California

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