1+ months

IRT Global Oversight Team Operations Sr Associate

San Jose, CA 95123
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Reporting to Director of Clinical Research Pharmacy Group with a dotted line reporting to the IRT Global Oversight team (IGOT) Director. 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.

The IGOT Operations Associate role will assist with functions including authorship and/or maintenance of required system documentation, programming queries, and SOP's, as well as system testing and report validation in 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 be a creative problem solver and have a strong commitment to quality to successfully deliver optimal IRT systems across a diverse and dynamic portfolio.

This role will provide support in the development and management of IGOT team SOPs and training documents as well as generating, testing, and validating necessary system SQL reports and performing system documentation reviews required for audit preparedness.


+ Provides application support to customers in an appropriate manner (blinded vs unblinded) using the Pfizer Internal IRT Systems. Customers include IGOT team members, supply chain personnel, and study team members.

+ Resolves and document issues reported by customers following the established processes.

+ Creates, verifies and validates ad hoc system study reports (e.g. SQL) upon request and provides to study team or supply chain personnel as needed.

+ Analyze system updates against SOP's to evaluate for impact to IGOT procedures and assists with the creation of applicable training.

+ Ensure the inclusion of appropriate study documents in both the IGOT Support regulatory SharePoint space as well as the Gnosis system

+ Review IRT study generated documents for confirmation of completion in preparation for regulatory audits.

+ Support IRT system testing, reporting, and monitoring efforts


**Basic Qualifications** :

+ Fluent in written and spoken English

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

+ 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** :

2-3 years of experience with IRT systems preferred

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

Database query (SQL), business analysis and technical writing skills a plus

Skilled in working across multiple systems and processes for issue resolution desired


Travel is limited to approximately 15% for this role

May include international travel for annual department meetings


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Logistics & Supply Chain Mgmt
Posted: 2020-10-13 Expires: 2020-12-13
Sponsored by:
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IRT Global Oversight Team Operations Sr Associate

San Jose, CA 95123

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