Clinical Operations Manager: Monitoring

1 week ago

Australia Bristol Myers Squibb Full time
Job Summary

Bristol Myers Squibb is seeking a highly skilled Clinical Operations Manager to lead and manage a cross-functional Clinical Operations Unit. The successful candidate will be responsible for the execution of phase I-IV clinical studies and will oversee the delivery of clinical operations effectiveness in RCO across Australia and New Zealand.

Key Responsibilities
  • Team Leadership: Supervise and coordinate the work assignments and performance of Clinical Operations staff (Clinical Trial Monitors).
  • Communication and Influence: Demonstrate the ability to effectively communicate with and influence individuals at all levels of the organization, including situations of conflict resolution, problem solving, and crisis management.
  • Resource Management: Anticipate resource needs and provide workload evaluations and task assignments.
  • Study Execution: Supervise clinical trial execution at country level, including supervising study metrics and team performance.
  • Financial Management: Approve study fee funds and payments based on grant of authority.
  • Country Targets: May propose and/or validate country study targets.
  • Regulatory Compliance: May support Health Authority inspection and pre-inspection activities.
  • Audit Preparation: May support audit preparation and Corrective Action/Preventative Action preparation for local related issues.
  • CAPA Implementation: Ensure Study Corrective Action/Preventative Action (CAPA) implementation and ensure the necessary resources/tools are available.
  • Goal Setting: Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met.
  • Performance Management: Together with the RCO management, tracks and manages performance metrics for Clinical Operations staff.
  • Initiative and Adaptability: Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit.
  • Collaboration: Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health, and/or Health Authorities as needed.
  • Account Management: Manage partnerships with critical accounts/sites.
Requirements
  • Experience: A minimum of 5 years of pharmaceutical industry experience in clinical research (monitoring) or medical affairs, including significant experience in planning, conducting, and managing clinical programs, with supervisory/leadership/mentoring experience and the ability to drive project-related activities.
  • Education: Bachelor's Degree within Life Sciences or equivalent.
  • Knowledge and Skills: In-depth understanding of GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs. In-depth knowledge and understanding of clinical research processes, regulations, and methodology. Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management. Demonstrated organizational and planning skills and independent decision-making ability. Strong organization and time management skills and ability to effectively manage multiple competing priorities. Outstanding interpersonal, oral, and written communication skills to influence, inform, or guide others. Good verbal and written communication skills. Independent use of Microsoft Suite and Clinical Trial Management Systems.

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