Clinical Research Trials Manager

2 weeks ago

Sydney, New South Wales, Australia beBeeClinical Full time $187,500 - $243,000

Job Title: Clinical Research and Trials Leader

 

We are seeking a skilled professional to drive innovation in clinical research and trials. This role will be responsible for developing solutions to improve clinical trial efficiency, reduce costs, and increase patient access to novel therapeutics.

 

The team will focus on innovating and incubating technological solutions to streamline clinical research infrastructure at sites conducting clinical trials. The successful candidate will work closely with site staff to establish clinical research infrastructure and collaborate with the Applied Innovation team to design methods for delivering novel technology at clinical sites.

 

This is an exciting opportunity for a results-driven individual with expertise in development and implementation of FICS at Clinical Trial Sites. Key Responsibilities:

 

  • Provide operational expertise on Sponsor and Site interface of FICS
  • Provision of expert knowledge on clinical trial compliance with local and global regulations
  • Support Applied Innovations and vendors with implementation of novel technology
  • Participate in problem-solving discussions with internal and external stakeholders
  • Train Applied Innovations team members and other stakeholders within the organization and work closely with Clinical Transformation Lead to develop training program and tools
  • Identify pain points in major workflows by contributing to development of wireframes/templates and tools to address these challenges
  • Surface suggestions on improvements in software and processes
  • Assist with development of novel technology (FICS), data capture forms and instructions
  • Clinical Research Associate experience
  • Mastery of Project Management with an ability to lead cross-functional working groups and teams
  • Hands-on experience of managing project and study budgets
  • Proven matrix leadership to accomplish team and organizational objectives
  • Significant understanding of the overall drug development and commercialization process
  • In-depth work experience of Ph1-3 Oncology development process
  • Full grasp of the latest research and thinking
  • Solid knowledge competitive landscape and activities
  • Demonstrated ability to shape and deliver business cases
  • Excellent written and verbal communication skills as well as proven negotiation, collaboration, and interpersonal leadership skills
  • Experience of leading a development team and working in a global environment
  • Willingness to travel both domestically and internationally
  • Conceptual, analytical, and strategic thinking
  • Ability to influence strategically across all levels of the organization
  • Expert with clinical operations systems such as EDC, RTSM, CTMS, and eTMF
  • Professional understanding of different core functions within the Clinical Trial ecosystem ie. Clinical Operations, Clinical Development, Data Management, and Biostats
  • Develop, create, and track SOPs, Policies, and Procedures
  • Other tasks delegated as needed

 

Requirements:

Bachelor’s degree and a minimum of 8 years of experience in Oncology Clinical Trials or Master’s degree and a minimum of 6 years of experience in Oncology Clinical Trials

Effective problem and conflict resolution skills and proven team focus

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