Premier Research helps highly innovative bio-pharmaceutical 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 pediatric research. We’re looking for a talented and energetic Associate Database Developer to join our team! Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
The Associate Database Developer serves as a member of the project team with primary responsibility for assisting with developing project databases, tools, and utilities using Clinical Data Management Systems (CDMS) and underlying database platforms.
•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 Premier Research standard operating procedures and/or client standard operating procedures
•Programs field derivations, edit checks, consistency checks, validations, procedures and rules.
•Writes data extraction programs
•Development 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
•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
•All other projects as assigned
EDUCATION, SKILLS & COMPETENCIES:
•Bachelor’s degree or equivalent years of experience in clinical research, drug development or healthcare environment
•1+ year’s Clinical database development experience
•Clinical trials support or pharmaceutical industry experience preferred
•Prior experience using computerized information systems preferred
3. Expertise and know-how
•Working knowledge of ICH and local regulatory authority drug research and development regulations preferred
•Understanding of database development processes, SOPs, and working guidelines
•Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development
•Knowledge of web based communication tools for conferences
•Strong English communication and listening skills (verbal, written & interpersonal)
4. Personal skills & behaviours
•Excellent team player, collaborative and able to work effectively with a team
•Ability to multitask in a fast-paced environment with changing priorities
•Strong verbal and written communication as well as negotiation skills
•Excellent organizational and time-management skills, able prioritize work to meet deadlines
•Accountable, dependable and strong commitment
•Customer service focused in approach to work both internally and externally
•Maintains a positive, results orientated work environment