Active participation in relevant industry organizations (e.g., PHUSE, CDISC), a plus.
Demonstrated experience serving as Business or Application System Owner for a GxP platform, preferably in a SaaS or cloud-hosted model.
Experience reviewing vendor validation documentation and leading UAT/regression testing in a regulated environment.
For US based candidates, the proposed salary band for this position is as follows:
Bachelor's or Master's degree in statistics, biostatistics, computer science, or related field and/or 10+ years of experience in pharmaceutical/biotech environments supporting validated GxP computerized systems.
Experience supporting inspection readiness, internal audits, and regulatory inspections.
Experience operating within a vendor-based validation model and assessing business impact of SaaS platform releases.
Practical knowledge of statistical programming environments (e.g., SAS, R) and associated file, package, and workflow management.
$164,080.00---$246,120.00
Strong working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP SDLC, change control, and data integrity principles (ALCOA+).

Research Teaching Assistant

Adecco

Trenton, NJ 08618

Pay rate:$30/hr
This is an entry level position and will be beneficial for anyone with an interest in clinical research, public health or community outreach.
Hours: Onsite, Monday through Friday, 8:30 am – 5:00 pm
Prior experience with statistical software (e.g. SAS, SPSS), bilingual skills (English/Spanish) a plus.
Research experience is preferred.
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements
Location: 135 E State Trenton NJ 08625