Clinical Study Manager

1 week ago

Sydney, New South Wales, Australia beBeeClinical Full time $98,000 - $118,000
Clinical Research Associate Job Summary">

Key Responsibilities:

  • Develop and execute clinical study protocols, case report forms (CRFs), annual reports, and other study materials.
  • Conduct site assessments to identify and select suitable investigator sites for clinical studies.
  • Responsible for all site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors, and other duties as assigned.
  • Facilitate communication between investigators and site research teams to prepare necessary documentation for the Ethics Committee (EC) and manage EC questions.
  • Coordinate the execution of study agreements.
  • Establish and maintain strong relationships with site personnel through regular communication throughout the study duration, focusing on driving study recruitment and compliance in accordance with protocols.
  • Identify, evaluate, report, and ensure adequate follow-up of adverse events per study protocol, company SOPs, and applicable regulations.


Requirements:

  • Degree-level education in life sciences or related field.
  • 3-5 years of experience as CRA with proven monitoring experience either with a healthcare company, Clinical Research Organisation (CRO), or hospital/healthcare provider. Experience in a medical device company, preferably in Orthopaedics, is preferred.
  • Good computer skills: good knowledge of Microsoft Office, including MS Outlook, Word, Excel, and PowerPoint.
  • High attention to detail.
  • Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one-to-one setting.
  • Effective interpersonal skills with ability to work in a team or independently as required.
  • Ability to multi-task and manage priorities with effective organisational and time management skills.
  • Demonstrated flexibility and adaptability.
  • Highly motivated with a proactive approach to learning and problem-solving.
  • Ability to travel up to 30%, depending on the stage and needs of the clinical study.

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