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Sr. Database Design Analyst (Clinical Systems)
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Country: USA
Location: New Jersey-Northern Jersey City, NJ 07311
Total applied: 40 |
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Sr. Database Design Analyst (Clinical Systems)
Sr. Database Design AnalystClinical SystemsJersey City, NJSummaryThis position is responsible for defining and configuring databases for data collection, programming edit checks, and creating paper or Electronic Data Capture (EDC) case report forms for Phase I through IV clinical studies. Contributes to the quality and timeliness of the Database Design group's deliverables at a study level. Duties and Responsibilities-Works with Data Management to create CRF/eCRF specifications ensuring consistency with the protocol and compliance with the project and global-level standards. -Create EDC and paper CRF annotations defining the data collection structure ensuring compliance with project and global-level standards. -Design and implement databases that facilitate efficient data capture ensuring compliance with the project and global-level standards. -Program edit checks according to study specifications that are accurate and completed in a timely fashion. -Participate in meetings, discussions and activities covering aspects of Database Design for all assigned studies. -Maintain efficient interfaces (consulting, training, and support) with internal and external customers in consultation with Clinical Systems & Medical Coding management as needed to ensure clinical study/project milestones are met. -Identify and finalize data file structure and layout specifications for transfer of study related external electronic data for loading into database. -Responsible for the set up of the database and loading the data into the database for the study related external electronic data received. -Evaluate the impact of study/project changes on the databasedesign/structure and edit checks and associated timelines and negotiate resolution of issues with the study team. -Provide assistance/leadership on technical, study, and project level to junior level staff. -Support manager in the coordination of all database design activities for assigned clinical projects/studies. -Support head of Database Design to define and achieve the goals of Clinical Systems and Medical Coding. -Participate in process improvement initiatives related to CRF/eCRF and database design including SOP, Working Document, and Guideline development. -Provide input and review documents for assigned studies (e.g., protocol, edit check specifications). -Provide support for Database Design activities outsourced to CROs/ASP providers. -Participate in industry groups and events to enhance knowledge, skills, and training. -Participate in the validation and implementation of new system applications. -Complete training requirements as defined by FRI Training and Development RequirementsEducation: Bachelors Degree or equivalent experience in computer science or related field. Experience: A minimum of six (6) years experience as a database developer and edit check programmer in the pharmaceutical/biotechnology industry. Licensure/Credentials: None. Knowledge, Skills, and Abilities: -A minimum of 3 years experience with Clintrial or similar clinical data management system. -A minimum of 3 years experience with InForm or web-based EDC data collection application. IF you are interested in applying for this position, please apply directly at: http://www.frx.com/careers/job_description.aspx?number=93629or review all of our open positions at www.frx.com/careers
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