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Clinical Project Manager

2 weeks ago

Sydney, New South Wales, Australia beBeeProject Full time $90,000 - $125,000
Job Overview

The Study Start-Up Manager is accountable for project planning, site start-up activities and activation deliverables of assigned projects in compliance with global standards, regulatory requirements and organizational processes.

Main Responsibilities
  • Supports country strategy in close collaboration with cross-functional teams.
  • Collaborates with stakeholders to ensure timely delivery of site start-up activities.
  • Accountable for on-time completion of site start-up activities from project initiation until activation milestone.
  • Ensures effective communication with local authorities and stakeholders.

In addition to the above responsibilities, the successful candidate will also:

  • Ensure that site start-up activities are conducted and completed on time, including preparation of submission packages, review of informed consent forms and engagement with regulatory affairs for submissions.
  • Prepare and finalize submission packages for local authorities and regulatory bodies.
  • Coordinate timely response to deficiency letters in collaboration with stakeholders.
  • Coordinate reportable events and notifications to local authorities and stakeholders.
  • Accountable for timelines, accuracy and quality of study documents to ensure inspection readiness.
  • Ensure adherence to financial standards, prevailing legislation, global standards and organizational requirements.
  • Implements efficient processes aligned with organizational strategy.
  • Supports study feasibility in collaboration with stakeholders.
  • Leads site selection in collaboration with stakeholders.
  • Oversight of local vendor management as needed.
Key Qualifications
  • Strong project management capabilities with problem-solving and conflict resolution skills.
  • Thorough understanding of international aspects of drug development process, including knowledge of global standards, regulatory bodies and organizational requirements.
  • Strong interpersonal, negotiation and conflict resolution skills.
  • Effective communication in a global matrixed environment.
Ideal Background
  • Advanced degree in scientific or health discipline preferred.
  • Fluent in written and spoken English.
  • Minimum 5 years' experience in clinical operations with project management or monitoring clinical trials.
  • Capable of leading in a matrix environment without direct reports.
  • Understanding of all aspects of clinical drug development with emphasis on trial set-up, execution and monitoring.