Job Title: Clinical Programmer
Location: Berkeley Heights, NJ
Duration: One year from start date, with possible extension
Pay Rate: $70
Responsibilities will include, but are not limited to: --Oversee and monitor CRO DB Build (in Medidata Rave) to ensure that Celgene standards are implemented in all studies --Schedule and lead eCRF design meetings --Routinely interface with cross-functional team members --Proper management of project priorities and timelines required --Review clinical programming activities and costs in contracts --Develop, program, test and maintain clinical trial databases and data entry screens using Medidata Rave in accordance with Celgene standards --Review validation/edit checks for in-house and outsourced studies --Act as liaison with vendors and oversee CRO to establish external data transfer specifications --Retrieve data from CRO and external vendors. --Develop, program, test and maintain data review listings in Jreview and/or SAS for data review purposes --Provide technical expertise and support to Data Management team --Make data available to company personnel and regulatory agencies when required --Perform post processing of data extracts in accordance with Celgene standards to be delivered to Biostatistics (if in-house study) --Coach and advise junior programmers to identify problems and solutions
KNOWLEDGE/SKILLS/ABILITIES (KSA's) - in order of importance:
--BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience --Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation --Advanced knowledge of clinical database design is a must (Medidata Rave experience is most important. Inform and Oracle Clinical or other systems are of lesser importance). --Good communication skills is a must --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 --Medical or mathematics/computer science background a plus --Knowledge of SQL and SAS programming --Knowledge of clinical trial design and basic statistics (a plus)
Sthree US is acting as an Employment Business in relation to this vacancy.