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eCRF / EDC Programmer

Job Description- Lead the delivery of Electronic Case Report forms (eCRFs) that are aligned with both study protocols and industry standards. This will include developing the eCRF technical specifications, leading study teams in approving the eCRF specifications, overseeing external vendors in the development of the eCRF, designing data capture forms, and programming and validating edit checks. This role will work closely with the Data Standards Organization in developing new standards aligned to CDISC standards, as well as partnering with key stakeholders such as Data Management, Clinical, Statistics, and Programming to ensure alignment with the clinical trial requirements. In addition, this role will lead and support customers with their programming and technical requirements for various systems used by the Data Acquisition team. Responsibilities include, but are not limited to: Contribute to the technical strategy and delivery for global clinical projects, which will involve working with representatives from multiple project teams, such as Data Management, Data Standards, Statistics, and Programming, o Provide technical input to protocol and other clinical plans during the initial development stage of a study o Coach and mentor colleagues and customers with programming best practices. o Provide input to the development of data capture tools for a clinical study o Adhere to best practices, process, SOPs and Guidelines o Ensure data programming procedure are of the highest quality and are audit ready o Act as a Subject Matter Expert (SME) for our partners, as well as provide programming  expertise, implementation and communication of programming control documents. Why You? Basic qualifications:  o Bachelor's Degree or higher in mathematics, statistics, computer science or related discipline.  o Has proven experience in creating specifications, managing timelines, leading cross functional teams and overseeing vendors  o Experience with Data Management tools, technologies and processes   o Ability and eagerness to learn new processes, programming languages and adapt with new technologies in a fast paced environment Preferred qualifications:  o eCRF programming and development experience in creating eCRFs utilizing any of the industry eDC tools (e.g. Central designer, RAVE) o Data extraction experience  o Lead study teams in eCRF trial development, specification builds , and ensuring alignment with the clinical protocol o Provide oversight of vendors to ensure that they are delivering clinical data based on the protocol requirements and technical specifications o Act as technical expert for Therapeutic areas and provide project support. o Expert in database programming and programming languages including PL/SQL, SAS o Assess database design requirements relevant to data capture tool, data extraction, processing and reporting. o Manage the design specification, development, testing and validation of electronic case report forms, edit checks standards and dataset extraction. o Make recommendations to management concerning complex technical issues and provide solutions. o Have a complete E2E technical and strategic understanding of products relevant to Data Management. o Knowledge of regulatory requirements for electronic submissions. o Accountable for audit readiness for data acquisition process and documentation o Able to manage multiple studies and projects simultaneously and deliver to the timelines Required degrees: Bachelors Experience required: 2 years Requisition ID: WD178014
Salary Range: NA
Minimum Qualification
Less than 5 years

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