Associate Database Developer
Company: Premier Research
Reference: Database - UK
Closing Date: 17 Nov 16
Type: Full Time
Salary (£): Competitive
Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and paediatric research. We strive to do different things and to do things differently.
We are currently looking for an Associate Database Developer - this role is to be office based in Sofia, Bulgaria.
Live chat link - https://flashrecruit.com/user/MeghanGriffin
- 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
EDUCATION, SKILLS & COMPETENCIES:
- 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
- Knowledge of Medidata Rave or DataLabs EDC is a plus
- 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 organisational and time-management skills, able prioritise 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.