Manager, Clinical Operations

Brisbane, Australia

ResApp Health is an ASX-listed digital health company building software to assist doctors and empower patients to diagnose and manage respiratory disease. Our growing team combines cutting-edge technology with world-class science to deliver breakthrough mobile health solutions. We have an active clinical pipeline of product candidates across a number of diagnostic and disease management areas and have partnerships with leading hospitals in Australia, the United States and Europe. We are looking for a Manager, Clinical Operations to manage operational aspects of ResApp’s clinical development programs. This role would be based out of ResApp’s headquarters in Brisbane, Australia.

Responsibilities

  • Actively manage the day-to-day operations of multiple, simultaneous clinical studies across multiple countries
  • Lead the development of the protocol and other study documents, e.g. consent templates, study reference manual, monitoring plan, data management plan
  • Participate in assessment and selection of clinical research organisations (CROs), sites and other vendors
  • Maintain performance and quality metrics for clinical study conduct, including patient recruitment timelines
  • Review clinical documents and clinical sections of regulatory documents for accuracy, consistency and quality

Qualifications

  • A degree in a science/health-related field
  • A minimum of 3 years of clinical research and/or clinical project management experience
  • Experience in the operational aspects of managing clinical studies from start-up to closeout
  • Excellent working knowledge of Human Subjects ICH GCP guidelines, FDA, CFR, EMA, and HIPAA regulations
  • Ability to prioritise tasks and resources to meet deadlines
  • Excellent communication and organisation skills
  • Ability to travel up to 10% of the time and participate in early and after-hours events and calls

To apply please send a cover email and a copy of your resume to careers@resapphealth.com.au.

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ResApp Health Limited
ABN 51 094 468 318
Headquarters: Level 8, 127 Creek St, Brisbane, QLD 4000
Registered Office: Level 24, 44 St Georges Tce, Perth, WA 6000

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+61 8 6211 5099
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In the United States, ResAppDx is an investigational device and is not available for sale.

© 2019 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327 and Patents Pending. ResApp Health®, the ResApp Health logo and ResAppDx® are registered trademarks of ResApp Health Limited in the United States and other countries.