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Analyst, Risk Management

Company: Reata Pharmaceuticals Inc.
Location: Plano
Posted on: June 13, 2021

Job Description:

The role of the Risk Analyst is to provide Risk Management support for both Reata clinical studies and programs and at an overall corporate level. At a study-level, the Risk Analyst will be assigned to several studies and support various activities to ensure overall study-level risks are managed, including adherence to ICH GCP E6-R2. At a corporate level, the Risk Analyst will be assigned to work with several functional areas and support various activities to ensure execution of the Enterprise Risk Management (ERM) process. The Risk Analyst will also support the development of the Risk Management (RM) Department and (RM)-led initiatives and projects.

RESPONSIBILITIES:

Specific responsibilities of the role may include the following:

Study Risk Management

  • Assist with the cross-functional development and maintenance of study-level Risk Assessment Plans to identify and appropriately categorize study risks thereby helping to ensure study objectives, scope and timelines are achieved, clinical study data is of high quality and compliance to GCP is adhered to
  • Perform trending/outlier data analysis and review key risk indicators to support the identification of risks/issues and communicate findings to relevant stakeholders
  • Identify potential areas for further data analytics
  • Assist in the development of study-level visualizations to enable robust and efficient data analysis
  • Participate in the Oversight Risk Committee (ORC) Meeting process including assisting with collating agenda topics, participating in discussions, and generating meeting minutes
  • Assist in the maintenance of study-level RM documents including Risk Assessment Plans and risk trackers to ensure adequate management of risk signals and tracking of mitigation plans
  • Collaborate cross functionally with internal stakeholders (e.g. Clinical Program Operations, Product Development/Statistics, Data Management, Bioinformatics, Safety, and QA) and with third party vendors (where appropriate) to ensure all identified issues are tracked and mitigation plans are followed through to completion
  • Participate and provide RM updates (where applicable) on cross-functional clinical study team and operational meetings
  • Assist with the review and provide feedback on relevant clinical program documents (e.g. study protocols, monitoring plans, data management plans)
  • Assist Quality Assurance with the development of Corrective and Preventative Action (CAPA) plans for issues of non-compliance (where applicable)
  • Corporate Risk Management
  • Facilitate Reata's Enterprise Risk Management (ERM) process by supporting the ERM process for assigned functional areas. Responsibilities include assisting functional areas identify and categorize risk, tracking and reporting risks, assisting with generation of agendas, participating in meetings, and generating meeting minutes

Projects/Initiatives/Other Activities

  • Assist on RM-led initiatives to evolve and optimize Reata's risk management capabilities which may include evaluating and implementing RBM technological solutions, and reviewing and optimizing internal and cross-functional processes
  • Support the development of RM guidance and training content and provide RM training to internal stakeholders
  • Support maintenance and updates to RM-related SOPs and other controlled documents
  • Support the development and growth of the RM Department including periodically reviewing/refreshing RM Department trainings, and tracking RM activities/milestones/deliverables

CORPORATE COMMITMENTS:

  • Demonstrate commitment and support for company goals, objectives, and procedures
  • Represent Reata by developing collaborative relationships with site personnel, colleagues, and vendors
  • Demonstrate professionalism and adherence to moral, ethical, and quality principles
  • Participate in corporate and departmental meetings
  • Comply with applicable regulations, GCP and corporate policies and procedures

QUALIFICATIONS:

  • A minimum of a BS or equivalent degree is required in Engineering, Science, or related field with 2-3 years' work experience managing data in regulated field; or an advanced degree (e.g. Master's, Ph.D.) with 0-2 years' work experience
  • Experience analyzing data in regulated spaces such as pharmaceutical industry (e.g. clinical operations, data management, biostatistics, CRO, or other relevant clinical development experience), medical devices, or food and drug is preferred
  • Strong scientific literacy required
  • Experience using Microsoft Office applications required (emphasis on Excel and PowerPoint); advanced Excel experience preferred
  • Experience with data visualization tools such as Tableau, Power BI, Spotfire a plus but not required
  • High emotional intelligence and ability to collaborate with diverse team; very strong communication skills required
  • Must have excellent time management skills and a strong sense of responsibility and follow-through
  • Must possess an intellectual curiosity and desire to learn, with high internal drive
  • Strong quantitative, analytical, and problem-solving skills
  • Demonstrate an ability to properly assess risks and their potential impact, and based on these analyses, appropriately identify when a communication and/or escalation is warranted
  • Must be able to quickly learn, understand, and apply new information, tools, and technologies

Keywords: Reata Pharmaceuticals Inc., Plano , Analyst, Risk Management, Other , Plano, Texas

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