Principal Data Acquisition Programmer

Employment Type

: Full-Time

Industry

: Information Technology



Your tasks and responsibilities The primary responsibilities of this role, Principal Data Acquisition Programmer, are to: Support programming for setup of study clinical data collection, reporting tools based on standards/ protocol requirements ensuring a high level of consistency and quality within and across studies Monitor and maintain ongoing library (i.e., programs, diagnostics etc.) level operation of DAS computing environment based on established standards and responds to user problems Develop and implement standardized tools to facilitate data management actions in preparation for Database Lock Support implementation of import and export integrations based on processes established by Technology & Integrations Understand protocol and compound requirements and be responsible to translate them to technical specifications Work with the standards library team (i.e., DA Standards Experts, DIS Compound Experts etc.) to create catalog of reports - reflecting clinical data as well as study, patient, or monitoring status Ensure that standard, generally accepted software development and testing techniques are used and that all solutions are of the highest quality and conform to all DAS/CI&A SOPs & Good Programming Practices (GPP) Estimate the time and resources needed to complete assignments. Track work progress and provide status reports to supervisor and study team members Responsible for completion of documentation associated with programming tasks (e.g. peer review, report specifications etc.) in compliance with applicable SOPs Assist in training of new programmer analysts or temporary staff in DAS procedures, computing environment, clinical research concepts and project requirements. Recommend strategies to avoid or minimize operational problems identifies opportunities for efficiency gains and develop proposals to realize them Support study close out activities including close out of integrations as applicable Perform other duties as assigned Who you are Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: Required Qualifications: Master's degree with 6 years of experience or Bachelor's degree with 8 years of experience Master's/Bachelor's degree in a natural science, Statistics, Computer Science or a related field In-depth experience in programming on commonly used technology platforms (i.e. RAVE, LSH, Oracle Clinical) for data acquisition and associated review, and reporting (i.e., JReview, SpotFire) is required Demonstrated leadership of small teams of programmers delivering a technical implementation in clinical study support is required Knowledge and experience in programming languages such as C#, SQL, SAS is required Effective time management skills to ensure completion of assigned task within planned timelines Hands-on experience with the tools and utilities for the management of pharmaceutical sponsor proprietary or industry clinical data standards i.e. sponsor specific or CDISC) is required Understanding of industry standards on integration technology such as web services and odm.xml is also required Understanding of global regulatory requirements, rules and guidances associated with Source Data in Clinical Investigations including Part 11 is required Understanding the principles of system design, database and edit programming is also required Experience in comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle is required Experience in project management tasks and managing multiple libraries/studies as assigned is desired Effective interaction and training of teams in the understanding and usage of standards and technology is desired Effective written and verbal communication in English and usage of Microsoft Office is also necessarySalary Range: NAMinimum Qualification8 - 10 years
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

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