Job Title: Vendor Qualification Associate I

Location: Foster City, C

Duration: 12+ Months

Hybrid: 3 days a week minimum

Description

Client is looking for a Vendor Qualification Associate I, who will report to the Senior Manager of Vendor Outsourcing. The candidate will be responsible for ensuring high quality of data and services across all vendors supporting Gilead’s global R&D portfolio – Ph I-IV clinical trials.

The candidate should have a deep understanding of vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities as they will be leading and/or supporting those cross-functional efforts. The candidate should also have an understanding of various clinical trial activities such as clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.

The Vendor Qualification Associate I is expected to complete tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.

Demonstrates a thorough knowledge of Good Clinical Practice “GCP”, Good Pharmacovigilance

Practices “GVP”, Good Laboratory Practice “GLP”, Good Documentation Practice “GDP” and ICH E6 R2 compliance requirements.

Demonstrates a thorough understanding of current global and regional trends in compliance. Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.(1) PMP certification or equivalent certification, (2) Candidates can be current or former project managers & (3) Project management experience in Pharmaceutical or Healthcare industries

Required Years of Experience: 3-5 years

Top 3 Required Skill Sets: 1) R&D Clinical Procurement Experience (2) Candidates can be current or former project managers & (3) Deep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries and Excel

Top 3 Nice to Have Skill Sets : Vendor Outsourcing, Subcontractor Management, Vendor Contracting and System skills ( Veeva, RDMS,TMF etc.)