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IRT Technical Lead - Impala 2.0

Company: Pfizer
Location: Groton
Posted on: April 5, 2021

Job Description:

United States - Pennsylvania - Collegeville The IRT Global Oversight Team (IGOT) is a well-established high performing team within Pfizer's Global Clinical Supply unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes. What You Will Achieve This IRT Technical Lead role will be the primary technical point of contact for Impala 2.0 system with focus on enhancement releases, troubleshooting, technical and system support strategies, quality investigations, business continuity, and data standards and stewardship. This role will report to the Head of IGOT with dotted line to the IRT Systems Lead and collaborate closely with IGOT Implementation and Support teams, Digital Clinical Supply Chain (DCSC) colleagues, technology partners, and Pfizer Digital. For this position, candidates must have excellent technical and analytical thinking skills, be creative problem solvers, have strong command of a variety of systems and databases, demonstrated leadership skills, and be willing to work flexible hours to maintain business continuity for our clinical trial sites and patients. How You Will Achieve It

  • Lead study level risk assessments in collaboration with IRT Systems Lead, IGOT Engagement, Design, and Support teams, to ensure study and system requirements are met and in alignment with data integrity and stewardship requirements.
  • Provide technical insights during design review meetings.
  • Partner closely with IGOT Support on Impala 2.0 system testing, support strategies and issue resolution.
  • Partner with applicable System Owners and technical team to ensure business continuity during planned releases and unplanned outages.
  • Lead testing workstream for patch and enhancement releases; including identification of risks to current studies, developing and contributing to execution of the testing plan.
  • Oversee impact assessments of system updates on iView2 reports.
  • Lead the resolution of technical issues and oversee quality investigations related to Impala 2.0 in collaboration with other technical/Digital resources. Provide customer facing input for technical consultations, audits and regulatory inspections.
  • Maintain and monitor Impala 2.0 data standards, quality, compliance, security and usage of IRT related entities that reside in DCSC's data dictionary and contribute to the overall data strategy for Global Clinical Supply.
  • Evaluate data requests related to IRT and propose/implement potential solutions. Qualifications Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Must-Have
    • BA/BS, in computer science, scientific, or business field with work experience in the biopharma industry required.
    • Masters or advanced degree a plus.
    • Minimum 9+ years of experience with IRT systems required.
    • Understanding the nature of clinical data, with regard to the concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards.
    • Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams.
    • Experience with root cause analysis, using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram.
    • Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus.
    • Possesses strong English language written and verbal communication skills.
    • Comfortable working with a global team, partners and customers in a change agile and matrixed environment. PHYSICAL/MENTAL REQUIREMENTS
      • Expertly skilled in a variety of data base query or reporting tools such as SQL, Spotfire, Tableau.
      • Skilled in Microsoft Office suite including advanced skills with Excel, PowerPoint, Project, Visio, OneNote and SharePoint.
      • Business analysis and technical writing skills a plus.
      • Skilled in use of HP ALM Quality Center preferred. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
        • Will require occasional after-hours support particularly on software release dates and unexpected system outages. Other Job Details:
          • Eligible for Employee Referral Bonus: YES
          • Eligible for Relocation: NO 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. 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. Logistics & Supply Chain Mgmt#LI-PFE Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Keywords: Pfizer, Newton , IRT Technical Lead - Impala 2.0, IT / Software / Systems , Groton, Massachusetts

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