Job Details

  • Title:
    Clinical Programmer
  • Code:
    RCI-CLG-07645
  • Location:
    Berkeley Heights New Jersey (NJ) 07922
  • Posted Date:
    04/15/2019
  • Duration:
    13 Months
  • Status:
    Open
Recruiter Contact Detail

  Job Description

Responsibilities will include, but are not limited to:

 

  1. Review computer validation/edit checks for in-house and outsourced studies
  • Develop, program, test and maintain computer validation/edit checks SAS
  • Develop, program, test and maintain data review listings in Rave, 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 Celgene standards
  • Validate peer programming
  • Participate in and lead team meetings when appropriate
  • Act as primary CRO contact, when necessary, to ensure that Celgene standards are implemented in all studies
  • Provide technical expertise and support to Data Management team
  • Make data, including interim 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
  • Routinely interface with cross-functional team members
  • Influences other functions and represents as DBO technical expertise
  • Internal team leader who decides best course of action
  • Coach and advise junior programmers to identify problems and solutions
  • Manage outside CROs and consultants:
  • Review clinical programming activities and costs in contracts
  • Interact with CROs in the design and development of databases that are compatible with company needs
  • Monitor progress of clinical programming activities in CROs
  • Participate in regular team meetings and provide input when appropriate

 

  1. Other Activities
  • Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock.
  • Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities
  • Managing project priorities and timelines

 

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).****
  • Participation in at least one NDA is preferred
  • 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
  • Medical or mathematics/computer science background a plus
  • Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation
  • Knowledge of SAS programming (nice to have).
  • Computer skills: detailed knowledge of clinical database design (Rave), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite
  • Knowledge of clinical trial design and basic statistics (a plus)