Clinical Study Risk Manager

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Date: Aug 8, 2019

Location: Raleigh, North Carolina, US

Clinical Study Risk Manager

UCB Biosciences

Raleigh - Durham - RTP, NC

Job Summary

The Clinical Study Risk Manager (CSRM) develops and executes the Key Risk Indicator (KRI) Monitoring plan to identify and triage risks then determine and track recommended mitigatory actions through completion.  The CSRM also supports the development a robust risk management plan by contributing to and driving the identification of critical data to optimize the use of data surveillance cross-functional activities to monitor key study risks. 


 Major Accountabilities

  • Pro-actively identify key risks, critical data and critical processes to contribute to the development of the cross-functional risk mitigation plan based upon protocol summary, protocol and other pertinent key documents. 
  • Identify study CRF data collection needs not addressed by UCB standards and pro-actively notify and engage data standards team as appropriate. 
  • Critically review and approve or provide directed feedback:
  • Critical variables (in consultation with Global Statistical Sciences)
  • Edit check specifications (ensuring critical risks assigned in the cross-functional risk mitigation plan are addressed)
  • Contribute to the study definition of important protocol deviations (IPDs) and proactively advocate for IPDs to be data derived   
  • Develop Key Risk Indicator (KRI) Monitoring Plan for review and approval by study team based upon study risk assessment.
  • Execute Key Risk Indicator review in accordance with KRI Monitoring Plan and document review of KRIs and any associated risks/issues and action items. 
  • Analyze, manage and report status of trends and backlog for KRIs and associated action items.  Proactively communicate and escalate as appropriate.  
  • Lead change agent within study teams to help embed risk-based monitoring within the organization.  Support the organization’s philosophy to work in cross-functional global teams.
  • Participate in and actively contribute to meetings to discuss study, site, and patient level trends and identify potential risks and issues.
  • Contribute to the development/improvement of relevant processes, tools, KRI analytics, and training for centralized risk monitoring.
  • Such other responsibilities and projects that the Company may assign.

Education and Qualification

  • Bachelor’s Degree is required
  • Minimum 5 years in the area of pharmaceutical research and development or related field preferably in clinical study management, site monitoring, data management, and/or biostatistics.
  • 1 – 2 years of clinical experience.
  • Demonstrated experience analyzing and evaluating data to make decisions and determine appropriate responsive actions. 
  • Working knowledge of medical terminology, government regulations, and Good Clinical Practice.
  • Knowledge of regulations and industry guidance documents governing quality by design and risk-based monitoring.
  • Prior, small scale, experience leading/participating in initiatives involving process and/or procedure development and leading change.
  • Demonstrated experience communicating with all levels of personnel and participating in collaborative work team (locally and globally).
  • Demonstrated experience managing multiple tasks concurrently and responding rapidly to changing priorities with aggressive timelines.



  • Strong analytical skills and attention to detail.
  • Ability to challenge and influence study team colleagues and other stakeholders to help embed risk-based monitoring within the organization.
  • Ability to adapt to change, work in a rapidly changing environment and manage uncertainty.
  • Ability to effectively organize ideas for logical presentation and acceptance.
  • Project management skills.
  • Ability to set personal objectives and determine appropriate courses of action.
  • Ability to adapt to working in a multicultural environment with teams located globally.
  • Ability to work with limited close supervision.
  • Analytical in nature and able to understand the rationale and interpret the content of clinical protocols and associated risk assessments for the purposes of developing and executing a fit for purpose KRI monitoring plan.
  • Demonstrated communication, interpersonal, organizational and problem solving skills.
  • Computer proficiency.
  • High levels of initiative, drive and commitment.
  • Proficiency in English, written and verbal
  • Ability to assess and prioritize the clinical implications of data signals/trends and determine appropriate mitigatory actions.
  • Ability to gather facts and data, to evaluate processes and situations in an orderly and rational manner, ask questions, and identify missing information.
  • Ability to quickly identify, analyze and solve problems, communicate any trends in the data appropriately to the applicable/responsible stakeholders, prior to risks/issues becoming critical.

Job Segment: Clinic, Risk Management, Medical, Manager, Pharmaceutical, Finance, Healthcare, Management, Science

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