Database Design and Development Associate

Date: 16 Jul 2025

Site: Elizabeth Street (Melbourne)

Location:

MELBOURNE, VIC, AU, 3000

Company: Peter MacCallum Cancer Centre

Unit: Biostatistics & Clinical Trials

Division: Cancer Research

Department: Office Of Cancer Research

Enterprise Agreement: Health and Allied Services, Managers and Administr

Biostatistics & Clinical Trials

At Peter Mac we aim to continuously improve cancer care, research and education across all cancers and for all people affected by cancer: changing lives, breaking new ground. Everything we do is underpinned by our core values, Excellence, Compassion and Innovation. Welcoming people from a wide variety of different backgrounds and experiences is critical to fostering innovation, cultivating compassion, attracting and retaining top talent and providing the best possible cancer care for our patients.

YOUR ROLE IN OUR FUTURE

Database Design and Development Associate (Clincal Trials)

15-months Fixed-Term (parental leave replacement), Full -Time
80 hours per fortnight with monthly ADOs
Attractive salary packaging offers available

About The Team

Based at Peter Mac for over 40 years, the Centre for Biostatistics and Clinical Trials (BaCT) provides a full range of services to clinical trials to facilitate the advancement of patient treatments and improved outcomes for cancer patients.

BaCT services include data management, statistics and project management to support a diverse range of clinical trials including Investigator-initiated studies, Company sponsored trials and Collaborative group studies

About The Role

As Database Design and Development Associate (Clinical), you are responsible for designing, programming, validating and maintaining clinical trial databases to support high quality data capture.

You will work in a cross functional collaborative team to ensure high quality data collection.

You will have the opportunity to interact directly with our Principal Investigators, collaborative groups and the experienced internal BaCT team and act as the primary subject matter expert for all CRF/DB design and management questions.

Requirements for the role include:

Experience in programming of specialist databases (preferably clinical data), and a high understanding of data structures.
Familiarity with Viedoc, RedCAP, RAVE and other industry used Data base systems
Familiarity with ICH-GCP, 21 CFR Part 11 and CDISC.
Leadership in functional implementation of databases / systems.
Strong operational and planning skills in order to meet deadlines and to handle multiple studies.
Accurate with an excellent attention to detail and a methodical approach to work
Able to work independently, be self-directed and capable of working to deadlines

Our Benefits

We offer a range of benefits which support our people both personally and professionally, including:

Up to $11,660 in salary packaging to increase your take home pay
Discounted health insurance and eye care
A comprehensive health and wellbeing program
Public transport options at our doorstep and end of trip facilities for cyclists
Onsite eateries and coffee shops and inviting rooftop garden spaces
Pathways for professional development and new career opportunities
Five weeks annual leave, 17.5% leave loading, purchased leave options
Flexible, hybrid working practices

Join us!

If you feel this role is right for you we warmly invite you to apply, and encourage your early application. All appointments are made subject to a satisfactory police check and may include vaccination requirements. Should you need assistance or require any adjustments or accommodations to fully participate in the application or interview process, you are welcome to reach out to the contact person listed. We acknowledge that not all applicants will meet the full list of selection criteria outlined, and wherever possible we will consider applications where relevant experience can apply.

Applicants to this role should provide a covering letter outlining relative key skills and experience to assist us with our assessment.

For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position summary. Alternatively, please contact us using the information below for a confidential discussion.

Hiring Manager: Maria Farrell - Clinical Operations Manager

Email: Maria.Farrell@petermac.org

Contact Number: (03) 8559 7533

Applications Close: 30 July 2025

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Position Summary

Responsible for designing, programming, validating and maintaining clinical trial databases to support high quality data capture.

Ensures that database development documentation are in place to support timely data capture and analysis reporting for clinical trials in line with regulatory requirements

Enterprise Agreement

Health and Allied Services, Managers and Administrative Workers (Victorian Public Sector) (Single Interest Employers) Enterprise Agreement 2021-2025

Classification or Salary Range

HS3

Immunisation Risk Category

Immunisation Category C

Key Relationships

Internal	Clinical Trial Management Team, BaCT Peter Mac Study Investigators Peter Mac research database programmers and data managers Statisticians
External	Clinical Trials Sponsors Representatives including pharmaceutical and collaborative groups( local and global) Data Management Vendors

Education

Bachelor of Information Technology

Skills

Essential Requirements

Experience in programming of specialist databases (preferably clinical data), and a high understanding of data structures.
Familiarity with ICH-GCP, 21 CFR Part 11 and CDISC.
Team player with the ability to work in a multi-disciplinary environment. Includes leadership in functional implementation of databases / systems.
Strong communication, organisation, written and verbal skills
Excellent conceptual thinking skills.
Strong operational and planning skills in order to meet deadlines and to handle multiple studies.
Accurate with an excellent attention to detail and a methodical approach to work
Proficiency with common business software
Able to work independently, be self-directed and capable of working to deadlines.

Desirable Requirements

Life Sciences / Information technology graduate (or equivalent) or relevant experience working in programming / pharmaceutical / research environment or Contract Research Organisation (CRO).

Certifications, Licenses & Registrations

Key Accountabilities

Key Accountabilities	Demonstrated by / Key Performance Indicators
1. Key Effectiveness Areas	Responsible for timely, high quality delivery of clinical data capture services in line with clinical study project requirements including: Design and create eCRF, study database and associated database development documentation Define and develop data quality checks in collaboration with study team Validate eCRF and study database System administration support including site user training Collaborate and co-ordinate with other functional groups to ensure integration of data outputs meet timelines and format required for further analysis e.g. data extracts to statistician Ensure activities are performed in line with regulatory guidelines Provide training, guidance, assistance and technical support to study team as required to facilitate the effective use of the study database and report functionality Proactively seeks innovative ways to improve data management functions. Communicates potential improvements to clinical team. Undertake additional tasks deemed necessary to meet business needs e.g. site / investigator data management support.
2. Database and eCRF Development and Quality Processes	Ensure data can be captured and reported in a logical timely manner and conforms to data standards. eCRF reflects the protocol design and conforms to data standards. Develop timelines for development processes. Data Validation Plan andndash ensure appropriate quality checks have been defined for the study including both electronic and manual checks to ensure completeness, integrity and quality of study data. Perform User Acceptance Testing (UAT) of the CRF and study database (including a review of database structure, data entry screens and data quality checks) to ensure that the data collection modules are designed and sequenced according to protocol and in compliance with protocol. Support data development / management SOPs as applicable.
3. Leadership and Engagement	Establish effective communication strategies fostering open and effective lines of communication at all levels. Assist in the leadership and conduct of specific projects as required. Contribute to study team meetings. Ensure CRF training is provided and data management requirements are communicated. Provide regular detailed feedback regarding study status and data quality issues to study team using metrics to identify and improve processes. Facilitate effective use of database to internal and external customers and report functionality.

Key Accountabilities (Contd..)

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For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position profile. Alternatively, please contact us for a confidential discussion.

Peter Mac is a child safe organisation and has a commitment to child safety and wellbeing.

WHY WORK FOR PETER MAC

Peter Mac offer a range of benefits which support our people both personally and professionally.
Our staff benefits include award winning facilities, professional development and events, a health and wellbeing program, flexible work practices and policies and financial benefits such as salary packaging.
We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQI community and people with a disability.