Pfizer IRT Data Steward in Groton, Connecticut

The IRT (Interactive Response Technology) Data Steward is a new role within the well-established IRT Global Oversight Team (IGOT). This role will be responsible for performing data management activities that support Pfizer's internal and vendor IRT systems. The IRT Data Steward will work independently and collaboratively and utilize a broad skillset of clinical data management best practices to ensure that IRT data are protected and compliant with respect to privacy, confidentiality and data integrity.

Role Responsibilities

  • This role will have the following responsibilities:

  • Develop and maintain IRT data standards in alignment with cross-Pfizer standards

  • Data owner for IRT related entities that reside in GCS's data dictionary

  • Develop and maintain data integrity policies, KPI's and data quality measures for IGOT

  • Contribute to the overall data strategy for Global Clinical Supply with specific focus on IRT data

  • Responsible for defining standards for data that is transferred into/out of IRT systems:

  • Data integrations with distribution and clinical systems

  • Sourcing data to support interim analysis and End of study reporting

  • Ad hoc data requests, including inspection support

  • Responsible for establishing data quality metrics and data curation practices that support the lifespan of IRT data.

  • Support evaluation of new technologies and innovations related to IRT (e.g., data visualizations, machine learning, mobile apps, etc)

  • Support IRT Oversight Leads on quality investigations related to IRT data

Qualifications

  • BA/BS, in computer science, scientific, or business field required. Masters or advanced degree a plus

  • Minimum 5-7 years of experience in Clinical Data Management in the pharmaceutical industry, preferably with experience in IRT systems

  • Business analysis - ability to translate business requirements into actionable technology requirements

  • Understanding the nature of clinical data, with particular regard to the concepts of blinding, privacy protection, and data reconciliation

  • Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus

  • Experience with data ingestion, establishing or monitoring of data standards, integrating data from various clinical systems

  • Possesses familiarity of regulatory guidelines and industry standards with regard to Data Management.

  • Possesses strong English language written and verbal communication skills.

  • Able to travel among various Pfizer campuses and vendor sites

PHYSICAL/MENTAL REQUIREMENTS

  • Skilled in a variety of reporting tools such as Spotfire / Tableau, Dataiku DSS and SQL tools

  • Skilled in Microsoft Office suite including advanced skills with Excel, PowerPoint, Project, Visio, OneNote and SharePoint

  • Database query, business analysis and technical writing skills a plus

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Other Job Details:

  • This position may also be located in Collegeville, PA, New York, NY or Andover, MA

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.