Clinical Data Associate

**Acknowledgement of Country**:
CSIRO acknowledges the Traditional Owners of the land, sea and waters, of the area that we live and work on across Australia. We acknowledge their continuing connection to their culture and pay our respects to their Elders past and present. View our vision towards reconciliation

**The Opportunity**:

- **Bring your clinical data management experience to research**:

- **Supportive, rewarding, inclusive and truly flexible environment**:

- **Grow your career in an in-house Clinical Research Unit at CSIRO**

CSIRO’s Health and Biosecurity Business Unit is dedicated to conducting scientific research that develops products and services to address the complexity and interdependencies of human, animal and environmental health and biosecurity challenges to provide benefits to Australia and the world.

CSIRO Health and Biosecurity are seeking a Clinical Data Associate to join their Data Management team within CSIRO’s Clinical Research Unit (CRU) in their Human Health Program to work alongside scientists and industry partners to bring health products and technologies to market that are safe and effective resulting in health and economic benefits for Australia. Open to either of the two medical precincts in SHAMRI Adelaide SA or Westmead Health and Medical Research Precinct in Western Sydney NSW, the Clinical Data Associate will be responsible for research activities related to managing data collected as part of clinical trials and other human research studies and providing support for the development and modification of programs, processes, systems and policies that may impact CSIRO-wide clinical research projects, process improvements and initiatives. If you are experienced in clinical data management of large clinical trials complying with International Council of Harmonisation Good Clinical Practise (ICH-GCP) fundamentals and have a strong understanding of clinical trial data collection, cleaning and management process, then do not hesitate to apply. This role promises exposure to a broad spectrum of activities and allows for upskilling through on-the-job training, accelerating one’s professional development within the clinical data management function. You’ll be provided with guidance and support from the Data Management team to hone your skills within a highly collaborative and supportive work environment that your counterparts in the industry will be envious of.

**Your duties will include**:

- Supporting the Clinical Data Manager in activities related to ensuring high-quality, on-time data management deliverables and providing operational support as required.
- Assisting in the design, documentation, validation and User acceptance testing (UAT) of clinical trial data collection tools using an electronic data capture (EDC) system and/or other data collection systems such as electronic patient-reported outcome (ePRO)
- Drafting database design specifications (including configuration, data structures, and annotated CRFs)
- Creating and updating the electronic form Completion Guidelines
- Drafting the Data Validation Specification (DVS) document including the creation of test cases for edit checks of study-specific forms
- Ensuring the complete documentation for data management projects and assisting in the development of study-specific data management plans
- Working with the Clinical Trial Coordinator across multiple sites for query management and also performing external reconciliation.
- Assisting in MedDRA coding of Adverse Events and resolving or appropriately escalating quality/compliance issues.

**Location**:Adelaide SA (preferred) or Westmead Sydney NSW

**Salary**:AU$66k - AU$84k plus up to 15.4% superannuation

**Tenure**:Indefinite / Full-time

**Reference**:88138

**To be considered you will need**:

- Relevant bachelor’s degree or equivalent relevant work experience in clinical trials data management.
- Demonstrated working knowledge of national and international regulations, guidelines and best practices related to the conduct of clinical trials and data management
- Strong computer literacy and demonstrated experience with clinical trial software (such as REDCap) and MS Office suite.
- Prior understanding of the clinical trials processes
- Demonstrated ability to effectively manage competing priorities simultaneously and carry out non-routine tasks independently.
- Demonstrated ability & willingness to contribute novel ideas and approaches in support of scientific investigations.

For full details about this role please review the **Position Description.**

**Eligibility**:
**Flexible Working Arrangements**:
We work flexibly at CSIRO, offering a range of options for how, when and where you work.

**Diversity and Inclusion**:
We are working hard to recruit people representing the diversity across our society, and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish.

**About CSIRO**:
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