Job Details

  • Title: Clinical Programmer
  • Code: RCI-9467
  • Location: Berkeley Heights New Jersey (NJ) 07922
  • Posted Date: 05/19/2020
  • Duration: 7 Months
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  Job Description


Responsibilities will include, but are not limited to:
--Oversee and monitor CRO DB Build (in Medidata Rave) to ensure that clients 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 client 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 client 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)