CenterWatch

26 days old

Clinical Data Programming Manager

Whiz Finder
Fort Lee, New Jersey

Job Summary

Title: Clinical Data Programming Manager

Company: Pharmaceutical

Location: Fort Lee, NJ

Type: Permanent Role

Notes: No Corp to Corp

Job Description:

  • Manage clinical data programming tasks for multiple studies.
  • Provide programming support for study team members from the study start up to the end.
  • Review/generate specifications for the database, data transfer, SDTM mapping specs to ensure that documents and specification are consistent and comply with internal/industry standards.
  • Perform data reconciliation, data quality control, and program SAS edit checks.
  • Generate all necessary outputs (table, listing, figures) for ongoing data review meetings and RBM using SAS and Spotfire.
  • Review/generate/validate electronic submission deliverables such as SDTM datasets,
  • XML, aCRF, Reviewers Guide.
  • Perform Quality Testing/User Acceptance Testing of EDC systems.
  • Provide adhoc listing, reports and graphs to various teams on request from the ongoing and legacy studies.
  • Support quality control and quality audit of deliverables.
  • Contribute to activities in validation and implementation including standard reporting systems, SAS macro utility programs and associated tools.

Requirements:

  • Education level bachelor’s degree
  • Minimum of 5 years of hands on SAS programming experience in a pharmaceutical environment.
  • Strong understanding of clinical trial data.
  • Strong understanding of relational database components and theory.
  • Strong understanding of SAS Programming.
  • Experience with SAS Drug Development.
  • Experience with Pinnacle 21 Enterprise to validate and design studies.
  • Experience with Medidata Rave.
  • Experience with Sportfire.
  • Experience with Python and/or R highly desired but not required.
  • Strong knowledge of regulatory requirements and guidance (e.g. GCP, ICH).
  • Strong knowledge of industry standards with at least 5 years of hands on experiences (e.g. CDISC SDTM, ADaM, ODM, Define.XML).
  • Must have excellent oral and written communication skills.

Job Type: Full-time

Salary: $75,000.00 to $90,000.00 /year

Experience:

  • Regulatory guidance/requirements: 3 years (Required)
  • Pharmaceutical: 5 years (Required)
  • Clinical trial data: 5 years (Required)
  • SAS Programming: 5 years (Required)

Education:

  • Bachelor's (Required)

Categories

Posted: 2019-03-27 Expires: 2019-04-26

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Clinical Data Programming Manager

Whiz Finder
Fort Lee, New Jersey

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