IRT Technical Lead - Impala 2.0
Posted on: April 5, 2021
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
- 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
- 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
- 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
- Comfortable working with a global team, partners and customers
in a change agile and matrixed environment. PHYSICAL/MENTAL
- 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
- 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
- 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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