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Senior Clinical Data Associate

4 weeks ago

Melbourne, Victoria, Australia Avance Clinical Pty Full time

Senior Clinical Data Associate Opportunity

About Us

We are Avance Clinical, a Contract Research Organisation specialising in supporting drug development for the pharmaceutical and biotechnology industry.

With our founding roots dating back to the 1980s, we have a rich history of expertise in this area.

Job Description

The Senior Clinical Data Associate (SCDA) is responsible for supporting the Data Manager by drafting relevant documents and cleaning data on an ongoing basis as outlined in the SOP.

Core 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.
  • Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.
Departmental Responsibilities
  • Foster the on-going commitment to maintaining a healthy team culture and promoting good morale, by actively participating in regular Data Management Meetings.
  • 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.
Organisational Responsibilities
  • Embrace the core values of Avance Clinical and endeavour 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.
What We Offer
  • Stimulating work
  • Project diversity
  • An intellectual challenge
  • An agile & flexible workplace
  • Opportunity to progress
  • Stability
  • Sense of community
  • A leadership team that are working together on a common goal
  • Flexible work options
  • Great tools / tech to do your job
  • A competitive salary & an extra day's holiday for your birthday