The Associate Database Developer is responsible for designing, building, and testing clinical databases and electronic Case Report Forms (eCRFs) for EDC and paper studies. They also perform system testing, quality control, and collaborate with study teams to ensure data management needs are met.
Premier Research is looking for a Associate Database Developer - FS to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
- Creates electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies
- Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
- Communicate with data management and study management teams throughout all study start up activities to ensure team needs are understood and met.
- Designs, builds, and tests clinical databases according to Standard Operating Procedures (SOPs)
- Programs field derivations, edit checks, consistency checks, validations, procedures and rules.
- Writes data extraction programs
- Develops of study reporting environment which includes CRF and non-CRF (loaded) data in addition to transforming collected data to required reporting format.
- Produces database documentation including an annotated CRF
- Ensures database documentation is maintained for the Trial Master File (TMF)
- Works in collaboration with the sponsor and study team to define all technical elements of the Data Management Plan
- Performs system testing and Quality Control (QC) of specified deliverables
- May assist in maintaining the Clinical Data Management Systems global and program libraries
- May be required to undertake additional programming tasks as needed
- May be required to participate in a flexible coverage schedule based on business need
- Performs additional duties as assigned