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 Support Project Specialist role sits within the IGOT Support function and will be responsible for the support of clinical trials configured within the Pfizer Internal IRT Systems. This role is intended to ensure the patient focused delivery of customer support services in support of Pfizer’s evolving portfolio.
For this position candidates will need to have excellent customer service 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
* Provides first line application support to customers using the Pfizer Internal IRT Systems. Customers include study team personnel, supply chain personnel, study team members.
* Understands the unique study requirements and how those requirements are configured and supported via the Pfizer Internal IRT Systems post the study go live.
* Resolves issues reported by customers following the established processes.
* Collaborates with study team personnel and supply chain personnel to resolve issues reported by customers.
* Ensures that when communicating with blinded customers, that the blind is maintained.
* Provides break blind support to blinded site and study team members.
* Provides ad hoc report requests to study team personnel and supply chain personnel as needed.
* Documents all support related interactions via the IGOT Support ticketing systems.
QUALIFICATIONS
* BA/BS, in computer science, scientific, or business field required in biopharma industry.
* Some experience with IRT systems or clinical supply 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.
* Strong English language, written and verbal communication desired.
* 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.
* Skilled in working across multiple systems and processes for issue resolution desired.
* Experience participating in root cause analysis and quality investigations.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Responsible for participating in weekend and holiday coverage to ensure 24/7/365 support coverage of the Pfizer Internal IRT Systems.
Work Location Assignment: Hybrid
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