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 robust 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.