Principal Clinical Programmer (RAVE EDC)
Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Job Summary
Lead in the evaluation, implementation, and validation of packaged systems. Create, maintain, and oversee processes for providing end user support in EDC systems. Build studies and support other users to build studies in EDC and other GxP systems. Works as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis. Processes database programming change requests. Documents all work fully according to FDA regulations and guidances, and company SOPs. Actively promotes standards for the development and acquisition of, and serve as the SME for, GxP systems. Mentors/trains junior level clinical programmers.
Primary Responsibilities
· Lead the development, validation, and maintenance of clinical databases for clinical trials using a variety of validated software applications
· Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans
· Develop and maintain global library of clinical database forms, edit checks, and other regularly used programs and routines
· Implement and test data quality checks in accordance with the study data validation manual
· Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data)
· Serves as SME and facilitates integration of EDC systems to other clinical platforms such as CTMS, Reporting, IRT as needed
· Assist in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug
· Oversee the management of EDC, other GxP system user accounts and other help desk activities
· Track issues in EDC systems, work with EDC vendors to resolve, and escalate issues appropriately to senior management.
· Quickly learn new and/or advancements in software to become the SME for any technical question
· Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary
· Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance)
· Exhibit good time management and organization skills; the ability to work in an efficient manner and prioritize tasks to meet tight deadlines while maintaining the highest standards of work
· Keep management team abreast of issues, progress, and risks related to trial operations
· Support bid defenses from a technical SME perspective
· Participate in other clinical programming and data management activities, as required
· Participate in internal and external team meetings, as required
· Mentor junior level clinical programmers
· Adhere to all aspects of the Statistics & Data Corporation’s quality system
· Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
· Perform other related duties incidental to the work described herein
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
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