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Clinical Operations Manager: Monitoring

2 months 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 Clinical Operations Staff

Supervise and coordinate the work assignments and performance of Clinical Operations staff (Clinical Trial Monitors) to ensure the successful execution of clinical trials.

Lead Cross-Functional Teams

Lead and manage cross-functional teams to deliver clinical operations effectiveness in RCO across Australia & New Zealand.

Anticipate Resource Needs

Anticipate resource needs and provide workload evaluations and task assignments to ensure efficient use of resources.

Allocate Study Resources

Allocate and assign study resources in alignment with R&D and local research goals and priorities.

Supervise Clinical Trial Execution

Supervise clinical trial execution at country level, including supervising study metrics and team performance.

Approve Study Fee Funds

Approve study fee funds and payments based on grant of authority.

Support Health Authority Inspections

Support Health Authority inspection and pre-inspection activities to ensure compliance with regulatory requirements.

Manage Study Corrective Action / Preventative Action

Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources/tools are available.

Develop and Track Performance Metrics

Develop goals that are consistent with R&D and local research goals and priorities and take necessary actions to ensure that goals are met.

Point of Contact for FSP Staff

Point of Contact for FSP staff within the country.

Manage Staff Performance

Managing the hiring, performance management and succession planning of staff.

Participate in Performance Calibration

Participation in performance calibration and talent review meetings.

Collaborate with Cross-Functional Stakeholders

Ensure collaboration and information sharing with local country cross-functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources).

Represent RCO in Local Leadership Discussions

Represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager.

Manage External Partnerships

Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and/or Health Authorities as needed.

Manage Critical Accounts/Sites

Manage partnerships with critical accounts/sites.

Requirements

We are looking for a highly skilled and experienced Clinical Operations Manager with a minimum of 5 years pharmaceutical industry experience in Clinical Research (monitoring) or Medical Affairs. The ideal candidate will have:

  • Bachelor's Degree in Life Sciences or Equivalent

A Bachelor's Degree within Life Sciences or equivalent.

Deep Understanding of GCP and ICH Guidelines

In-depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.

Knowledge of Clinical Research Processes

In-depth knowledge and understanding of clinical research processes, regulations and methodology.

Organizational and Planning Skills

Demonstrated organizational and planning skills and independent decision-making ability.

Strong Communication Skills

Outstanding interpersonal, oral and written communication skills to influence, inform or guide others.

Technical Skills

Independent use of Microsoft Suite and Clinical Trial Management Systems.