Clinical Operations Director

19 hours ago

Melbourne, Victoria, Australia beBeeCompliance Full time $100,000 - $125,000
Job Title:

Clinical Operations Director

Job Description:

This role is responsible for leading and managing the daily depot operations, including staff management and operational scheduling. The Clinical Operations Director will oversee the receipt, storage, shipment, return, and destruction of stored materials according to standard operating procedures (SOPs).

The successful candidate will be responsible for ensuring compliance with all division, corporate, and regulatory requirements. This includes maintaining established procedures concerning quality assurance, security of controlled substances, and record-keeping.

Key responsibilities include:

  • Fulfills job responsibilities as a Technical Representative of the Clinical Trials Supply Chain Service in its country, according to legal requirements
  • Maintains and assures compliance with current ICH, GXP, FDA Good Clinical Practices, ISO guidelines or any other required in the position training program
  • Monitors the overall performance of staff members to ensure compliance with guidelines above
  • Ensures regulatory compliance standards are adhered to, and that regulatory information is transferred appropriately to local staff and the corporate compliance team
  • Manages the restrictions (scope, cost, time, human resources, etc.) to guarantee the depot complies with the expected performance indicators

Additional duties include: performing temperature-controlled environment tasks, physically packing shipments, participating in scheduled weekend tasks for stock control, balance sheet, and cold chamber cleaning processes, and leading continuous Improvement initiatives to ensure processes are streamlined.

Required Skills and Qualifications:

The ideal candidate will have a deep understanding of all protocols stored at the WC Depot to provide instructions to all the Depot Staff. They should be willing to be trained on EWP equipment and/or Forklift.

Strong leadership skills and experience in managing teams and ensuring compliance with regulations are essential for this role.

Benefits:

This role offers the opportunity to work in a dynamic and fast-paced environment with a competitive salary and benefits package.

Others:

As a Clinical Operations Director, you will be part of a global organization with a strong commitment to quality and customer satisfaction.

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