Clinical Data Associate Position

2 weeks ago

Melbourne, Victoria, Australia Avance Clinical Pty Full time
Job Overview

We are seeking a skilled and experienced Clinical Data Associate to join our team at Avance Clinical Pty Ltd. As a key member of our data management department, you will be responsible for supporting the Data Manager in drafting relevant documents and cleaning data on an ongoing basis.

Key Responsibilities
  • Develop study-related documents or plans under the supervision of the Data Team Manager.
  • Preparation of Data Management Plans and assist with development of Edit Check Document with the support of a mentor.
  • Preparation of clean and erroneous dummy data.
  • Perform data review and cleaning of data collected during the trial and raise queries in the database while conducting cleaning activities for eCRF studies.
  • MedDRA / WHO-DD Coding with the support of a mentor and/or review of coding.
  • Liaise with a variety of different team members to ensure good communication across each study.
  • Archiving of studies, including EDC specific documentation.
Departmental Responsibilities
  • Foster the on-going commitment to maintaining a healthy team culture and promoting good morale, by actively participating in regular Data Management Meeting.
  • Maintain effective communication with other members of the department.
  • Proactively identify risks related to departmental service provision and assist in their mitigation and resolution.
  • Participate in internal Quality Assurance activities as required, including responding to internal audit findings.
  • Embrace the core values of Avance Clinical and endeavor to display those attributes at all times with clients and staff alike.
  • Commit to Avance Clinical training programs.
  • Adhere to Avance quality systems.
Requirements
  • Bachelor's level degree in life sciences, pharmacy, nursing or equivalent field (highly regarded), or appropriate industry experience.
  • Previous experience as a CDA in a Contract Research Organisation (CRO) or Pharma company for at least 1 year.
  • Awareness of ICH GCP Guidelines and other applicable regulatory requirements (desirable).
  • Clear understanding of the requirement to adhere strictly to client confidentiality.
  • Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
  • Demonstrated ability to take initiative in problem solving and in exercising good judgement.
  • An understanding of Privacy Legislation as it applies to the Clinical Trial Environment (desirable).
  • Ability to work independently or in a team environment as needed.
  • Willingness to work in, and be supportive of, a positive and dynamic team culture.

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