Senior CDA Opportunity
Avance Clinical, a Contract Research Organisation, is seeking a Senior Clinical Data Associate to support our drug development services for the pharmaceutical and biotechnology industry.
This is an office-based role in Adelaide, Melbourne, Sydney or Brisbane. If you are a life science graduate with ICH GCP awareness, exceptional verbal & written communication skills and administration experience from a clinical trial background, we would love to hear from you.
About Us
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team and are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs.
Job Description
The Clinical Data Associate I (CDA I) 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 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 endeavour to display those attributes at all times with clients and staff alike.
* Commit to Avance Clinical training programs.
* Adhere to Avance quality systems.
Qualifications, Skills and Experience:
* 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
How to Apply:
* Please submit your CV & cover letter as one Microsoft Word document.
* You must have full Australian working rights to be considered.