1+ months

IRT Design Specialist, Manager

Pfizer
Groton, CT 06340
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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 SUMMARY**

The IRT Design Specialist is a new role within the Design team that is responsible for designing and validating studies in Pfizer's internal IRT systems. The implementation of this dedicated function within IGOT is intended to ensure the delivery of high quality IRT systems through focused system expertise while improving delivery velocity in support of Pfizer's evolving portfolio.



The IRT Design Specialist will be assigned at the requirements elicitation stage and will partner closely with IGOT's IRT Leads, Support (help desk) Team, Pfizer Digital (Business Technology), and Quality Assurance to ensure system requirements, standards, design and validation deliverables are consistently employed across programs while meeting portfolio timelines and demands.



The IRT Design Specialist will also partner with IGOT management

on quality investigations, CAPA commitments and continuous

improvements, SOP review and revision activities, and other limited duration teams where appropriate.



For this position candidates will need to have excellent technical and analytical thinking skills, be a creative problem solver, and have a strong commitment to quality to successfully deliver optimal IRT systems across a diverse and dynamic portfolio.



**ROLE RESPONSIBILITIES**



+ Design and configure internal IRT systems using requirements documentation supplied by IRT Leads while ensuring configuration standards are incorporated into system builds.

+ Manage the delivery plan for configuration and testing activities and communicate risks.

+ Partner with the IRT Lead to identify testing strategy and with Pfizer Digital to develop and deploy custom code or study specific logic (SSL) where needed to support complex study designs.

+ Create supportive IRT documents and provide system demo to IGOT and study team as part of system acceptance process.

+ Write and approve user acceptance testing (UAT) and summaries for assigned studies where UAT methodology is employed; track defects and support resolution.

+ Perform quality checks (QC) for studies that don't require UAT.

+ Support creation and maintenance of IRT standards for system configuration and UAT/QC processes and provide technical expertise and issue resolution for configuration, UAT and/or QC processes.

+ Support the development and delivery of training activities within the Design team to ensure knowledge of configuration, UAT and QC standards.

+ Support quality investigations and continuous improvement projects and provide input into SOPs and process development.



**BASIC QUALIFICATIONS**



+ BA/BS, in computer science, scientific, or business field desired in biopharma industry

+ Minimum 5+ years of experience with IRT systems required; Pfizer internal IRT and/or distribution system experience preferred

+ Understanding of the nature of clinical data, with particular regard to the concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards

+ Exposure to working in a GMP / GCP environment and with regulatory audit teams

+ Comfortable working with a global team, partners and customers in a change agile environment



**PREFERRED QUALIFICATIONS**



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

+ Strong English language, written and verbal communication desired

+ Skilled in use of HP ALM Quality Center preferred

+ Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram desired



**Other Job Details:**



+ Additional Location Information: Role can be based on-site in Groton, CT or Collegeville, PA.

+ Eligible for Relocation Package: NO

+ Eligible for Employee Referral Bonus: YES



**\#LI-PFE**



**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
Posted: 2020-09-14 Expires: 2020-11-14
Sponsored by:
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IRT Design Specialist, Manager

Pfizer
Groton, CT 06340

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