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IRT Lead, Senior Manager

Company: Pfizer
Location: Groton
Posted on: February 21, 2021

Job Description:

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 personnel.
  • 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 investigations.
  • 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 assigned studies.
  • 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 impact.
    • 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 a plus.
      • Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram.
      • 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 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. 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 place.

Keywords: Pfizer, Newton , IRT Lead, Senior Manager, Executive , Groton, Massachusetts

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