Clinical Database Developer

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.