Premier Research is looking for an Associate Database Developer to join our Data Management 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 Built for You. 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.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for Biotech. Join us and build your future here.
What you will be doing :
- Assists with Quality Control (QC) of specified deliverables
- Creates electronic Case Report Forms (eCRFs) according to finalized protocols for EDC studies
- Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
- Participates in database building design and testing according to Premier Research standard operating procedures in operation at that time
- Assists in programming field derivations, edit/consistency checks, and setup of screen flow in the CDMS for Data Entry
- Assists in writing procedures, validation and data extraction programs
- Produce database documentation including an annotated CRF.
- Ensure database documentation is maintained for the Trial Master File
- Works in collaboration with the Data Management project team, Statistician, Project Manager and the sponsor to define all technical elements of the Data Management plan
- May assist in maintaining the CDMS global and program libraries
What we are searching for:
- Educated to Bachelor’s degree level, or equivalent. In lieu of this qualification, 3 years of experience in clinical research, drug development or healthcare environment will be required
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web based communication tools for conferences
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
- Excellent team player, collaborative and able to build an effective team.
- Ability to multitask and work effectively in a fast-paced environment with changing priorities.
Why Choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
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