Job Details

  • Title: Clinical Programmer
  • Code: RCI-CLG-08297
  • Location: Berkeley Heights New Jersey (NJ) 07922
  • Posted Date: 08/12/2019
  • Duration: 12 Months
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  Job Description

Actual Job Title = Clinical Programmer

Duration = One year from start date

Typical Daily Work Hours = Mon-Fri, 40 Hrs/Wk, 9am to 5pm (some flexibility in start/end times)

Weekend & OT work = Not required

100% onsite work.

Responsibilities will include, but are not limited to:

  • Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with Celgene standards
  • Lead collaborative cross-functional team study build meetings for in-house and outsourced studies
  • Review edit checks for in-house and outsourced studies
  • Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and Celgene standards
  • 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
  • Control access to database and perform snapshots, database lock and freeze activities
  • 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
  1. Manage outside CROs and consultants:
  • Review clinical programming activities and costs in contracts
  • Assess CRO data management systems for regulatory compliance
  • 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
  • Direct responsibility for supervising and training junior clinical programmers in the performance of their duties
  • 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, Inform, Oracle Clinical or other systems). Safety Gateway, TSDV, Site Payments and Coder experience a plus
  • 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
  • Computer skills: knowledge of MS Office program suite
  • Knowledge of clinical trial design and basic statistics (a plus)