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 chance 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.
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