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Consultant, Data Manager, Pharmaceutical

Company: GForce Life Sciences
Location: New York
Posted on: May 16, 2022

Job Description:

SummaryOur client, a growing, mid-sized pharmaceutical client, has engaged GForce Life Sciences to provide a Data Manager Consultant. This position will report to Sr. Director within the Data Management department.This individual will be responsible for maintaining a project-level perspective on data management issues, activities, and deliverables. This position will be supporting the Contract Research Organization (CRO) and third-party vendor processes involved in developing data collection systems, data cleaning, and providing data deliverables conforming to global CDISC standards. Provide strategic input into protocol design from a data management perspective. Represent the Data Management Department on project teams and manages the flow of data from collection to submission. Work with representatives from all functional areas to develop and maintain consistency, accuracy, and quality of data across therapeutic areas.Duties / Expectations of Role

  • Works collaboratively with CROs and third-party vendors to design databases, define quality specs, and resolve data management-related issues.
  • Assists in developing and maintaining DM standards and processes for both in-house and CRO studies in accordance with applicable standard operating procedures (SOPs) and GCPs.
  • Provides consultation, leadership, and expertise to CRO DM and project teams on Data Management functions.
  • Acts as the Data Management lead for all assigned protocols, including contributing to the development and implementation of the project plan.
  • Ensure standard processes are followed by all CROs for data management activities. Train CRO personnel on current processes.
  • Uses software applications to monitor and evaluate CRO performance (e.g. query status, data trends, detecting outliers and study progress)
  • Acts as a resource to the contract staff to identify problems and propose solutions to maintain projects within designated timelines.
  • Proactively identifies and implements opportunities for process improvements.
  • Provides expert review and help in the development of CRF/eCRF/eSource design specifications, validation specifications and report design, etc. Works with external service providers to help troubleshoot and resolve problems.
  • Ensures the consistency of CRF design and coding across studies and programs.
  • Contributes to protocols, clinical study reports, Investigator Brochures, Statistical Analysis Plans, INDs, and other regulatory documents.
  • Prepares submission-ready Electronic Case Report Forms (eCRFs) to support electronic submissions.
  • Reviews SOW, provides input and ensures consistency across programs for Data Management activities to be outsourced to CROs.
  • Manages third-party vendors' (e.g., CROs, EDC/eSource, and ancillary) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables.
  • Communicates and interacts with CRO vendors to ensure that project timelines are met with quality.
  • Provides status reports on the progress of projects/programs to the internal team.
  • Ensures data management-related presentations for Investigator's meetings adhere to Otsuka requirements.
  • Provides input in the development of departmental and global SOPs.
  • Serves as a project team member and works closely with biostatisticians and programmers to provide quality deliverables.
  • Other tasks assigned by the Associate Director, Director, or Sr. Director of Data ManagementMandatory Requirements
    • Bachelor's degree required
    • Minimum of 3 years of experience in data management within the pharmaceutical industry.
    • Must have prior Project Management experience
    • Strong understanding of medical concepts and terminology
    • Knowledge of CDISC and industry standards
    • Strong working knowledge of data management practices and applicable global regulatory requirements
    • Strong working knowledge of electronic data capture systems, eSource, and familiarity with regulatory guidelines on the use of electronic systems.Nice to Have
      • Esource ExperienceTerm & Start
        • 12-month contract with a strong possibility of extension
        • Start 2 weeks from an offer
        • Full time, 40 hours/week
        • Princeton/Hybrid in office 1/2x a week is preferred. Remote possibility for the perfect candidate
        • Benefits included (Medical, Dental, Vision, 401k)
        • Vaccine required if onsite
        • Interview process - 2 Video interviews

Keywords: GForce Life Sciences, New York , Consultant, Data Manager, Pharmaceutical, Healthcare , New York, New York

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