Description

The Australasian Leukaemia & Lymphoma Group (ALLG) network is delivering break-through advances in the treatment of blood cancers, and our Data Manager role is a senior, expert role supporting our medical research group. Our vision is better treatment better lives, and the ALLG 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 design, development, and management of our clinical trial and registry databases using our premium electronic data capture (EDC) system.

• Provide expert guidance, support and training to 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 in clinical trial data practices.

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

• The design and build of new databases to support our clinical trial research program, through close working relationships with our development team, statisticians and medical leads.

• Extensive induction training will be provided for the candidate to learn our EDC system and to operate it with a high level of expertise. Ongoing investment in professional development.

Key Skills and Essential Criteria

• Demonstrated experience in data management, data capture designing electronic case report forms (eCRFs), data validation quality checks in order to query data (preferably experience with clinical trial data)

• Expert proficiency with EDC systems (Marvin by EvidentIQ preferred but not essential) including strong experience programming and validating new and/or existing clinical trial databases

• Demonstrated understanding of Good Clinical Practice, regulatory, ethics, privacy and other relevant guidelines in data management (CDISC, GCDMP, CDISC, ICH-GCP, 21 CFR Part 11)

• Experience with programming and design of databases, design of user acceptance testing protocols and data extraction processes

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

• Experience with SQL reports

• Understanding of medical terminology ideally oncology and haematology

• Demonstrated project management and organisational skills including the ability to work independently across tight timelines

• Excellent written and verbal communication skills

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

• High attention to detail

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 SOP development, use, and monitoring

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.

This position is available for IMMEDIATE START. For further information and to request the position description, contact Naomi Sprigg, ALLG Operations Manager, at ************@allg.org.au

Applications will be taken via the SEEK 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.