Biotech/Pharmaceutical

Medidata Rave Database Programmer – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description: Candidate responsibilities will include, but are not limited to:

  • Design and build database (in Medidata Rave) and ensure that all industry standards are implemented in all studies
  • Schedule and lead eCRF design and review meetings
  • Routinely interface with cross-functional team members
  • Proper management of project priorities and timelines
  • Develop, program, test and maintain clinical trial databases and data entry screens using Medidata Rave in accordance with industry 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 industry standards to be delivered to Biostatistics

Qualifications:

  • 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 are 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
  • Custom Function experience needed
  • Knowledge of SQL
  • Knowledge of clinical trial design and basic statistics and SAS programming (a plus)

Tagged as: Medidata Rave Database Programmer - Remote