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Temp- Global Study Start-Up Clinical Data Steward

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: November 23, 2021

Job Description:

Temp- Global Study Start-Up Clinical Data StewardThe incumbent will have responsibilities for the creation and management of Site information within operational systems, including but not limited to Organizations/Institutions, Investigators and other Site Personnel. Ensuring the quality of the information through frequent validation against internal and external data sources is core to the role.Investigator/Institution Global Directory

  • Collects relevant information to create investigator/institution profiles within the CTMS system according to the Sponsor standard (First Name, Last Name, Street Address, City, State, Country, Postal Code, Phone number, email, etc.).
  • Ensures the capture and management of relevant unique identifiers (eg. Veeva Vault, Citeline ID, Drug Dev/IQVIA Golden ID, NPI ##, etc.) to enable cross referencing and reporting requirements.
  • Routinely reconciles Organization and Person records to ensure that any potential duplicates are remediated according to existing business practices.
  • Leverages Sponsor and External data sources to verify Organization and Person contact information to ensure accuracy and completeness of the Sponsor standard.
  • May gather relevant study, country and site level information within the CTMS system (eg. Study/Country/Site Status, Planned/Actual Site Regulatory Package Approval date, Planned/Actual Site Initiation Visit Date, Planned/Actual Site Activation Date, etc.).
  • Engages with other SSU colleagues (Eg. SSU Associate Managers and SSU Mangers) to address Study specific reported data inconsistencies or missing records.
  • May engage with Global Development Systems and Solutions (GDS) resources to develop, implement and supervise the introduction of automated methods to upload, reconcile and handle Organization and Person directories.Requirements:Associates or Bachelor's degree and minimum 1-3 years of relevant/clinical systems data entry/management/administration experience.
    • Solid understanding of the clinical drug development process, ICH/GCP and regulatory guidelines/directives
    • Computer skills with competency in MS suite (eg. WORD, Excel, Powerpoint)
    • Familiarity and expertise in Clinical Trials Management Systems (CTMS), Trial Master File (TMF) and Metadata/Master Data Management
    • Familiarity with Veeva Vault Clinical
    • Ability to prioritize and manage multiple projects simultaneously
    • Demonstrates effective problem solving and decision-making skills
    • Interpersonal, teamwork and partner management skills, Good communication (written/verbal)
    • Highly organized, detail oriented
    • Ability to synthesize information and demonstrate critical thinking
    • Self-motivated, flexible, able to follow through in a fast-paced environment, ability to meet deadlines under pressure
    • May require up to 25% travel

Keywords: Regeneron Pharmaceuticals, Inc., Newark , Temp- Global Study Start-Up Clinical Data Steward, Healthcare , Basking Ridge, New Jersey

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