Location: Connecticut - Groton, USA
Company: Pfizer
Job Position: IRT Design Specialist
JOB DESCRIPTION:
Qualification:
Education & Experience
BA/BS, in computer science, scientific, or business field desired in biopharma industry.
- Minimum 2+ years of experience with IRT systems desired; 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 GMP / GCP environment
- Strong English language written and verbal communication preferred
- Comfortable working with a global team, partners and customers in a change agile environment
Job Responsibility:
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 communicates risks.
- Partner with the IRT Leads 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; document defects and support resolution.
- Perform quality checks (QC) for studies that don’t require UAT.
- Support creation and maintenance of IRT standards for system UAT/QC processes.
- Support quality investigations and continuous improvement projects and provide input into SOPs and process development.