IRT Lead, Senior Manager
Posted on: February 21, 2021
United States - New York - New York City United States -
Pennsylvania - Collegeville United States - Massachusetts - Andover
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
internal and vendor IRT solutions. As part of an innovative
clinical supply chain, we routinely challenge the status quo in
efforts to optimize our systems and processes.ROLE SUMMARYThe IRT
Lead is a new role within the Engagement function in IGOT that will
serve as a strategic partner and single point of accountability to
partner lines for protocol assessments, requirements elicitation,
system deployments, and resupply settings guidance for Pfizer's new
internal IRT system (Impala 2.0). The implementation of this new
role is intended to strengthen key interfaces within assigned
therapeutic areas, streamline processes and increase agility.--The
IRT Lead will be assigned when it is determined that an IRT system
may be needed at the draft protocol stage. He or she will perform a
preliminary protocol assessment with the Supply Chain Lead (SCL),
Clinical Research Pharmacist (CRP) and clinical team members (e.g.,
clinician, biostatistician) to determine the most effective IRT
strategy for clinical customer, investigator site, Global Clinical
Supply, and ultimately for the patient. The IRT Lead will present
the key preliminary requirements and IRT system recommendations to
the IRT Protocol Assessment Group for final determination.--For
internal IRT solutions (e.g., Impala 2.0), he or she will elicit
additional protocol requirements from the clinical team, then
partner with the IGOT Design and Support teams to ensure the
protocol is configured, test scripts are complete and appropriate,
and deployed to production successfully upon their successful
completion of User Acceptance Testing (UAT).The IRT Lead will also
partner with IGOT management for quality investigations, CAPA
commitments and continuous improvements, SOP review and revision
activities, support regulatory inspections, and limited duration
teams where appropriate.The IRT Lead will be therapeutically
aligned where feasible, serve as a member of the Clinical Supply
Team and as the IGOT POC throughout the life of the study. For
ongoing studies, he or she will also be available for guidance on
IRT resupply settings and any requisite system amendments.For this
position candidates will need to be able to think outside of the
box,--have excellent communication and analytical thinking skills
to successfully deliver optimal IRT solutions across a diverse and
dynamic portfolio.ROLE RESPONSIBILITIES
- Serve as a strategic partner and POC for protocol assessment
and IRT system selection for assigned studies.
- Elicit and document system requirements for new and amended
studies in partnership with the SCL, CRP and clinical team.
- Write and execute UAT test plans where UAT is employed.
- Create IRT supportive documents and deliver investigator
meeting slides to clinical teams and investigator site
- Train partnering lines on the system functionality applicable
to their study.
- Provide technical expertise and knowledge sharing across
engagement and system design teams to ensure consistency in
standards, design and strategic decision making.
- Contribute to or lead cross line initiatives and quality
- Provide input into SOPs and process development and aid in
quality investigations and CAPA resolution.
- Serve as the IRT representative on Clinical Supply Teams for
- Serve as subject matter expert during regulatory inspections
for assigned studies.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, life science, or business field
required in biopharma industry. Advanced degree desired.
- Minimum 9+ years of industry experience with IRT, clinical
supply, and/or business analysis desired.
- Understanding of the nature of clinical data and 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.
- Project management and/or continuous improvement experience or
certification such as PMP, CBAP, AIM or Lean Six Sigma Green
Belt/Black Belt a plus.
- Possess excellent English language written and verbal
communication, interpersonal, collaboration and business
partnership capabilities required.
- Comfortable working with a global team, partners and customers
in a change agile environment.PHYSICAL/MENTAL REQUIREMENTS
- Database query, business analysis and technical writing skills
- Experience participating in root cause analysis using tools
such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone
- Experience with business analysis and/or project management
tools a plus (ex. MS Project, MS Visio, HP Quality Center, or any
other requirements visualization and analysis tools).
- Comfort with facilitating requirements elicitation sessions,
modeling requirements, and negotiation of business needs as they
apply to system functionality.
- Ability to represent IRT function in a high-pressure
environment (e.g., during regulatory inspections).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. 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.
Logistics & Supply Chain Mgmt#LI-PFE Posted 6 Days Ago Full time
4805188 About Us 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
Keywords: Pfizer, Newton , IRT Lead, Senior Manager, Executive , Groton, Massachusetts
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