Clinical Operations Manager: Monitoring

1 week ago

Sydney, New South Wales, Australia Bristol-Myers Squibb Full time
About the Role

Bristol-Myers Squibb is seeking a highly skilled Clinical Operations Manager to lead our clinical trials in Australia and New Zealand. As a key member of our team, you will be responsible for the execution of phase I-IV clinical studies and will lead and manage a cross-functional Clinical Operations Unit.

Key Responsibilities
  • Supervise and coordinate the work assignments and performance of Clinical Operations staff (Clinical Trial Monitors)
  • 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
  • Anticipate resource needs and provide workload evaluations and task assignments
  • Allocate and assign study resources in alignment with R&D and local research goals and priorities
  • Supervise clinical trial execution at country level, including supervising study metrics and team performance
  • Approve study fee funds and payments based on grant of authority
  • May propose and/or validate country study targets
  • May support Health Authority inspection and pre-inspection activities
  • May support audit preparation and Corrective Action/Preventative Action preparation for local related issues
  • Ensure Study Corrective Action/Preventative Action (CAPA) implementation and ensure the necessary resources/tools are available
  • Develop goals that are consistent with R&D and local research goals and priorities and take necessary actions to ensure that goals are met
  • Together with the RCO management, track and manage performance metrics for Clinical Operations staff
  • Anticipate and initiate action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit
  • Point of Contact for FSP staff within the country
  • Managing the hiring, performance management, and succession planning of staff
  • Performing general and human resource administrative functions
  • Participation in performance calibration and talent review meetings
  • Ensuring collaboration and information sharing with local country cross-functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
  • When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be a member of the local affiliate leadership team managed by the General Manager
  • Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health, and/or Health Authorities as needed
  • Manage partnerships with critical accounts/sites
Requirements
  • A minimum of 5 years 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
  • Bachelor's Degree within Life Sciences or equivalent
  • 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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