Join the Australasian Leukaemia and Lymphoma Group (ALLG) as our Clinical Research Data Manager and make an impact in our health and medical research group working with experts who treat and support patients with different types of blood cancer. Our vision is better treatment better lives, and the ALLG Clinical Research Data Manager is an outward-facing team role that is pivotal in achieving this vision. The successful candidate will be an integral manager within the ALLG, responsible for:

· The development, design and build of our clinical trial databases using our premium electronic data capture (EDC) system, Marvin by EvidentIQ.

· Provide leadership for the data management processes across our clinical trials and clinical registry, to optimise data quality and the success of the clinical trial program.

· Lead external and internal meetings providing expertise.

· Engage with key stakeholders including globally recognised clinical trial research investigators, to strengthen collaborations.

· Work closely with our development team, including statisticians, to build new databases to support our clinical trial research program.

· Extensive training will be provided for the candidate to transfer their existing skills in EDC design and build to utilising the Marvin by EvidentIQ EDC system to a high level of expertise, with ongoing investment in professional development.

· Manage a direct report.

Key Skills and Essential Criteria

High level of expertise and proficiency with EDC systems including demonstrable strong experience in the design, programming and validation of new and/or existing clinical trial databases, and the development of supporting documentation.

Our EDC: Marvin by EvidentIQ preferred but not essential, at minimum knowledge of the CDISC Operational Data Model is expected

Proven experience designing electronic case report forms (eCRFs), data quality checks and supporting documentation in line with study protocols e.g. Data Management Plans and CRF Completion Guidelines

Experience extracting data from EDC systems for protocol-define analyses, including setting up custom reports using SQL queries

· In-depth knowledge and demonstrated application of relevant industry guidelines (ICH-GCP, 21 CFR Part 11), privacy laws, and applicable industry standards in data management (GCDMP and CDISC is desirable)

Understanding of medical terminology (oncology and haematology)

Demonstrated project management and organisational skills including high attention to detail, critical thinking and problem solving

Demonstrated vendor and stakeholder management skills, must have personal confidence to liaise with a variety of health and research professionals

Training and management of clinical trial data associate(s) and clinical operations staff in best database programming and data management practices

Desirable Criteria

Tertiary qualification in an information technology field or health- related field

Experience in central data management, ideally with multi-site clinical trials.

Familiarity with statistical programs and concepts

Experience in driving improvements in clinical data quality and data management practices through process development and implementation

Extensive experience with Microsoft Office Suite, specifically MS Access databases and MS Excel

The ALLG as a not-for-profit organisation offers charity status salary packaging entitlement. The position involves minimal travel but a willingness to travel interstate when needed is essential (approximately twice per year). The ALLG offers a highly flexible workplace, offering remote working options.

For further information and to request the position description, contact Jenny Collins, Project Manager, ALLG.

Applications will be taken via the SEEK/LinkedIn portal. Please include a cover letter addressing the key skills and criteria above and a copy of your current CV. Only candidates successful in gaining an interview will be notified.

We encourage people from all backgrounds to apply, including Aboriginal and Torres Strait Islander People, people from different cultural backgrounds and people with disabilities.