Manager, Clinical Operations
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.
- 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
- 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 firstname.lastname@example.org.
ResApp Health Limited
ABN 51 094 468 318
Level 12, 100 Creek St, Brisbane, QLD 4000
© 2020 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327, Japanese Patent No. 6,435,257 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. ResAppDx is not available for sale in the United States.