Lead Clinical Database Developer & eCRF Expert

Health and Aged Care Professionals; City of Melbourne; On-site; AUD 108,000 - 132,000; Full time

Job summary

Health and Aged Care Professionals in Melbourne seeks an experienced Clinical Database Developer to join the Data Management team. The role is hands-on, covering study start-up through go-live and close, with senior-level opportunities to mentor teammates.

You'll design eCRFs, develop databases, and implement validation checks, while ensuring data integrity and regulatory compliance across clinical studies. This is a full-time on-site role in Melbourne, Australia.

Qualifications

• Tertiary qualification in Science, Pharmacy or related discipline.
• 2+ years' clinical data management experience for the Clinical Database Developer level.
• For Senior level, 4+ years' clinical data management experience including at least 2 years building databases.
• Certification in a relevant EDC platform.
• Strong knowledge of ICH-GCP and regulatory requirements relating to clinical trials.
• Excellent written and verbal communication skills.
• Ability to work independently, prioritise effectively and proactively resolve issues.

Responsibilities

• Leading clinical database activities during study start-up.
• Designing and developing eCRFs and clinical study databases.
• Translating study protocols into data capture solutions.
• Developing and programming validation/edit checks.
• Configuring user roles and system access.
• Creating study-specific reports.
• Managing database go-live activities.
• Performing mid-study database changes and maintenance.
• Supporting database close and study completion activities.
• Training sponsors, sites, vendors and internal teams in EDC systems and CRF completion.
• Working closely with Clinical Operations, Biometric, Data Management teams, clients and external vendors.

Skills

Clinical database development

eCRF design

EDC systems

Data management

Validation checks

Role-based access

Data reporting

Cross-functional collaboration

Attention to detail

Education

Science/Pharmacy degree

EDC platform certification

Tools

EDC platform

Job description

Health and Aged Care Professionals in Melbourne seeks an experienced Clinical Database Developer to join the Data Management team. The role is hands-on, covering study start-up through go-live and close, with senior-level opportunities to mentor teammates.

You'll design eCRFs, develop databases, and implement validation checks, while ensuring data integrity and regulatory compliance across clinical studies. This is a full-time on-site role in Melbourne, Australia.