Clinical Operations Risk Manager

Bristol-Myers Squibb Princeton, NJ

About the Job

Description:

The Clinical Operations Risk Manager (CORM) supports the protocol team in ensuring quality is embedded across all phases of development and therapeutic areas. The role will also support Risk Based Monitoring (RBM) by facilitating the risk assessment discussion, and will ensure risks are mitigated from the time of protocol development to protocol closure. The Clinical Operations Risk Manager will be assigned as an extended study team member during study start up for Programs and/or Protocols that meet the criteria for RBM.

 

Specific Clinical Operations Risk Manager Responsibilities

  • Protocol Review\: Review clinical study protocol and amendment drafts; increase program/organization consistency and drive the finalization of Quality by Design (QbD) documents
  • Coordination of Risk Assessment activities\:
    • Facilitate Risk Assessment Categorization Tool (RACT) completion, and maintenance of RACT or Issues/Risks Log, as needed 
    • Develop and maintain Program Level RACT, as appropriate
    • Ensure consistent identification and scoring of operational risks and mitigation strategies across therapeutic areas
    • Develop and maintain library of risks and mitigation and monitoring strategies.  Share potential risks and mitigation strategies with teams at appropriate time points
    • Ensure alignment of RACT with protocol Plans (i.e. Site Monitoring Plan, Data Review Plan, Training Materials) and mitigation strategies
    • Conduct ongoing assessment of effectiveness of mitigation and monitoring strategies
    • Develop and present RBM training material to stakeholders as needed
    • Support teams in ongoing risk assessment, issue identification and documentation
  • Development of Training Materials\: Collaborate with R&D Learning to support development of protocol and/or amendment training material; ensure risk mitigation is embedded in training
  • Apply Learnings\:
    • Ensure Audit and Inspection learnings (CAPAs) are applied across Programs and Protocols
    • Drive and facilitate protocol specific quality focused Lessons Learned sessions at critical study milestones
  • RACT IT Solution Development\: Provide risk assessment expertise to support the implementation of an IT solution as part of an overall RBM solution.
Qualification:

Required capabilities (skills, experiences, competencies)\:

  • Minimum of bachelor’s degree
  • Candidates must be NJ based
  • Minimum 4 years of experience in clinical operations at a pharmaceutical company or CRO
  • Knowledge (ICH-GCP and EU directives) and experience of clinical trial conduct and methodology
  • Demonstrated ability to apply critical and strategic thinking, and distinguish relative importance to resolve issues
  • Therapy area experience over a number of therapeutic areas
  • Experience with Risk Based Monitoring or Risk Assessment activities (desirable)
  • Knowlege and experience with Health Authority Inspections, audits and/or CAPA responses
  • Demonstrated ability to drive change with innovative, independent, creative solutions
  • Must be able to work and manage time independently, but also has to work effectively as part of a team
  • Ability to multitask and work on several assignments simultaneously
  • Must possess an ability to assert self and drive engagement with development teams
  • Able to lead and facilitate efficient meetings
  • Constructive interaction with inter and intradepartmental team members
  • Good written and oral communication skills in the English language
  • Able to develop and deliver (technical) training
  • Excellent communication skills with the ability to summarize complex information.