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Clinical Programmer

New Jersey, Southplainfield, 07080 Southplainfield USA

IKCON PHARMA, INC, an affiliate of IKCON TECHNOLOGIES, INC provides innovative services & solutions to our clients who develop novel, modern medicines to improve the lives of patients globally. By utilizing digital technologies, we can transform how sponsors approach clinical development by improving the patient experience, enhancing clinical trial productivity, increasing the quality of data collected in trials, and incorporating valuable insights from multiple sources of data. We are currently looking for a Clinical Programmer with one of our clients in [South Plainfield, NJ ]If you are actively looking for opportunities, please send us your updated resume with your contact details. JOB TITLE Clinical Programmer CITY South Plainfield STATE NJ TAX TERMS W2 EXPERIENCE 5+ Years INTERVIEW MODE Telephonic/ Skype "U.S. Citizens and those authorized to work in the U.S. are encouraged to apply." JOB DESCRIPTION

  • Oversee and monitor CRO DB Build (in Medidata Rave) to ensure that company 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 in accordance with company 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 company standards to be delivered to Biostatistics (if in-house study)
  • Coach and advise junior programmers to identify problems and solutions
  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years of 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)
  • we are looking for entry level, 2-5 years, 5-7 years, 7-10 years

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