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Research and Analysis

Associate Director, Study Start Up (0.5 FTE) Part Time

Summary

TFS HealthScience, a global mid-size CRO with over 27 years of experience, seeks an Associate Director, Study Start Up for a part-time, remote role in Australia. The position focuses on managing study start-up activities for clinical research in ophthalmology.

Responsibilities

  • Perform start-up activities for assigned studies, ensuring on-time delivery, scope compliance, and adherence to ICH/GCP guidelines, SOPs, and protocol requirements.
  • Collect, review, approve, and track regulatory and investigator documents for study site activation.
  • Prepare and complete regulatory processes (IEC/IRBs), including requirements, documentation, submissions, amendments, and regulatory fees.
  • Collaborate with Regulatory department on HA/CA submission/notification.
  • Ensure quality control of documentation for submissions/notifications.
  • Adapt Informed Consent documents to local laws and document the process per guidelines and SOPs.
  • Ensure contracts are executed, regulatory documents and approvals are granted, IP Release is authorized, and project deliverables are completed.
  • Participate in site evaluation and feasibility processes for assigned projects.
  • Review and provide feedback on site performance related to start-up activities.
  • Maintain up-to-date start-up information and requirements in the central repository.
  • Ensure adherence and compliance with local regulatory requirements and documentation.

Requirements

  • Bachelor’s Degree preferred.
  • Good knowledge of GCP/ICH guidelines.
  • Good knowledge of applicable regulatory requirements, SOPs, and company’s Corporate Standards.
  • Minimum 5 years of relevant clinical experience.
  • Previous experience with investigator start-up documents and investigative sites preferred.
  • Good written and communication skills.
  • Good organizational skills and experience working with cross-functional teams.
  • Strong software and computer skills.
  • Capable of multitasking and working under pressure to meet deadlines.
  • Good understanding of working in a team environment.
  • Limited travel required.

Benefits

  • Competitive compensation package.
  • Comprehensive benefits.
  • Opportunity for personal and professional growth.
  • Collaborative and innovative work environment.

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