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Clinical Operations Manager: Monitoring

2 months ago

Australia Bristol Myers Squibb Full time
About the Role

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

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. Allocate and assign study resources in alignment with R&D and local research goals and priorities.
  • Study Execution: 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.
  • Regulatory Compliance: Ensure compliance with GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs.
  • Partnerships and Collaboration: 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
  • 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.
  • Education: Bachelor's Degree within Life Sciences or equivalent.
  • Skills: In-depth understanding of GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs. Strong organizational and planning skills, independent decision-making ability, and excellent communication skills.
About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to transforming patients' lives through science. We are committed to creating a diverse and inclusive work environment that promotes diversity in clinical trials and fosters a culture of innovation, urgency, accountability, inclusion, and integrity.