Associate Database Developer

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. Were a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.Were looking for anAssociate Database Developerto join
Functional Services
team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, youll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
Position Summary:
Assists with the development of project databases, tools and utilities for the Data Management department using the Clinical Data Management Systems (CDMS) and underlying database platforms. To serve as a member of the project team with primary responsibility for database design, validation and data extraction programming.
What youll 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
All other projects as assigned
What we are searching for:
Educated to Bachelors degree level, or equivalent. In lieu of this qualification, 0- 3 years of experience in clinical research, drug development or healthcare environment will be preferred.
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
Ability to adapt to changing priorities, take initiative and follow through on own
Attention to detail and ability to independently resolve a variety of issues without close supervision
Able to think creatively
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.
Strong verbal and written communication and negotiation skills.
Excellent organizational and time-management skills, able prioritize work to meet deadlines.
Accountable, dependable and strong commitment.
Is customer service focused in approach to work both internally and externally.
Maintains a positive, results orientated work environment.
Why choose Premier Research?
Premier Research is more than a company its 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 cultural anchors Caring & Empathy, Empowerment, Aspiration, One Team mirror the 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.

#LI-TB1