Clinical Database & EDC Engineer

Healthcare Professionals Group; City of Melbourne; On-site; AUD 110,000 - 170,000; Full time

Job summary

Healthcare Professionals Group is partnering with a clinical research organisation to recruit an experienced Clinical Database Developer. You will own the design, build and go-live of clinical databases across the study lifecycle, with opportunities to mentor teammates and shape database standards.

Ideal candidates hold a science-related degree with 2+ years in clinical data management, and Senior level applicants bring 4+ years’ experience and demonstrated database development.

Qualifications

• Minimum 2 years' clinical data management experience for the Clinical Database Developer level.
• Senior level: 4+ years’ clinical data management experience, including 2+ years developing clinical databases.

Responsibilities

• Lead clinical database activities during study start-up.
• Design and develop eCRFs and clinical study databases.
• Translate study protocols into data capture solutions.
• Develop and program validation/edit checks.
• Configure user roles and system access.
• Create study-specific reports.
• Manage database go-live activities.
• Perform mid-study database changes and maintenance.
• Support database close and study completion activities.
• Ensure data structures are consistent and fit for purpose.
• Provide expertise in clinical data capture and external data transfers.
• Train sponsors, sites, vendors and internal teams in EDC systems and CRF completion.
• Collaborate with Clinical Operations, Biometrics, Data Management teams, clients and external vendors.

Skills

Clinical data management

eCRF design

EDC systems

Database development

Validation/edit checks

Regulatory knowledge (ICH-GCP)

Data transfer & integration

Training & mentoring

Education

Science/Pharmacy degree

Tertiary qualification in related technical discipline

Tools

EDC platform

Clinical database design tools

Job description

Healthcare Professionals Group is partnering with a clinical research organisation to recruit an experienced Clinical Database Developer. You will own the design, build and go-live of clinical databases across the study lifecycle, with opportunities to mentor teammates and shape database standards.

Ideal candidates hold a science-related degree with 2+ years in clinical data management, and Senior level applicants bring 4+ years’ experience and demonstrated database development.