Medical Study Manager

2 days ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $96,000 - $124,000
Clinical Research Associate Role Overview

The Clinical Research Associate plays a pivotal role in managing clinical studies within the Orthopaedic implants and technology sphere. As a key member of the team, you will be responsible for ensuring that assigned studies are conducted in accordance with regulatory guidelines, local regulations, and standard operating procedures (SOPs). This involves developing strong relationships with site personnel, conducting routine monitoring and close-out of clinical sites, and maintaining study files.

  • Establish and maintain effective communication channels with site personnel throughout the study duration to ensure seamless execution.
  • Conduct thorough monitoring and close-out of clinical sites, adhering to regulatory requirements and SOPs.
  • Liaise with investigators and site research teams to prepare documentation for Ethics Committees and address EC questions in a timely manner.
  • Coordinate the execution of study agreements and foster collaborative relationships with vendors.
  • Evaluate, report, and ensure adequate follow-up of adverse events per study protocol, company SOPs, and applicable regulations.
Requirements

To excel in this role, you will need:

  • A degree in life sciences or a related field, with a strong foundation in scientific principles and methodologies.
  • 3-5 years of experience as a Clinical Research Associate with proven monitoring expertise, preferably within a healthcare company, Clinical Research Organisation (CRO), or hospital/healthcare provider environment.
  • Excellent computer skills, including proficiency in Microsoft Office applications and ability to adapt to new technologies.
  • High attention to detail and effective organisational skills, with the ability to prioritise tasks and manage multiple projects simultaneously.
  • Strong interpersonal skills and ability to work effectively in a team or independently, as required.
  • Ability to travel up to 30% depending on the stage and needs of the clinical study.
What We Offer

We provide a competitive remuneration package, opportunities for growth and development, and a dynamic team environment that values flexibility and adaptability. Our organisation is committed to fostering a culture of excellence, collaboration, and continuous learning.

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