Clinical Database Developer

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

The Opportunity

We are partnering with an established clinical research organisation seeking an experienced Clinical Database Developer or Senior Clinical Database Developer to join its Data Management team. This is a hands-on role for someone with strong experience in clinical database development, eCRF design and EDC systems, who enjoys working across the full study lifecycle from study start-up and database build through to go-live, maintenance and database close. For candidates operating at Senior level, the role will also provide the opportunity to act as a technical expert, support the development of database standards and mentor other team members.

You will be responsible for:

• Leading clinical database activities during study start-up
• Designing and developing eCRFs and clinical study databases
• Translating study protocols into effective 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
• Ensuring data structures are consistent, accurate and fit for purpose
• Providing expertise in clinical data capture and external data transfers
• Training sponsors, sites, vendors and internal teams in EDC systems and CRF completion
• Working closely with Clinical Operations, Biometrics, Data Management teams, clients and external vendors

About you:

• A tertiary qualification in Science, Pharmacy or a related technical discipline
• At least 2 years' experience in clinical data management for the Clinical Database Developer level
• For Senior level, at least 4 years' clinical data management experience, including a minimum of 2 years developing clinical databases
• Certification in a relevant EDC platform
• Demonstrated hands-on experience building clinical study databases
• Experience designing eCRFs and developing validation/edit checks
• Strong knowledge of clinical research processes and ICH-GCP
• An understanding of regulatory requirements relating to clinical trials
• Strong attention to detail and quality
• Excellent written and verbal communication skills
• The ability to work independently, prioritise effectively and proactively resolve issues.

Why consider this opportunity?

This is a great opportunity for an experienced clinical data professional who enjoys the technical/database development side of clinical research and wants to work across a varied portfolio of clinical studies.