Job Description Skills/Knowledge Required: BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years’ experience Advanced knowledge of clinical database design is a must (RAVE, InForm, Oracle Clinical) Demonstrated proficiency in creating standard operational metadata, and CDASH compliant CRFs In-depth understanding of CDASH and SDTM requirements Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers Knowledge of FDA/ICH guidelines and industry standard practices regarding programming Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation Knowledge of SAS programming Responsibilities will include, but are not limited to: Develop, program, test and maintain clinical trial databases and data entry screens using Oracle Clinical, Medidata Rave and InForm in accordance with Client standards. Develop standard CRF metadata per Client standards; contribute to the creation of CDASH compliant CRFs. Review computer validation/edit checks for in-house and outsourced studies. Develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS. Develop, program, test and maintain data review listings in Oracle Clinical, InForm, JReview and/or SAS for data review purposes. Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and Client standards. Participate in and lead team meetings when appropriate. Act as primary CRO contact as needed to ensure that Client standards are implemented in all studies. Provide technical expertise and support to data management and study teams. Control access to database and perform snapshots, database lock and freeze activities in accordance with Client SOPs. Make data, including interim data, available to company personnel and regulatory agencies when required. Perform post processing of data extracts in accordance with Client standards to be delivered to Biostatistics. Routinely interface with cross-functional team members. Additional Information All your information will be kept confidential according to EEO guidelines. J-18808-Ljbffr