Clinical Data Associate

New opportunity to join the Clinical Data team
- Supportive managers
- Global and stable CRO

**If you are a life science graduate, with ICH GCP awareness, that has exceptional verbal & written communication skills and administration experience preferably from a clinical trial background we'd love to hear from you.**

**Who are we?** We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

**Why should you join Avance Clinical?** 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. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

**The role**
The Clinical Data Associate I (CDA I) is responsible for supporting the Data Manager by drafting the relevant documents and cleaning the data on an ongoing basis as outlines 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.
- Organisational Responsibilities
- 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.

**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 days holiday for your birthday

**What next?** As a growing business we’re looking for likeminded people to join us - we hope that’s you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must have full Australian working rights to be considered