Internal Title: Vendor Qualification Associate I

Location: Foster City on site 3 days a week

Schedule: M-F 8:00-17:00

Contract/CTH: Contract with possibility of extension

Description

Client is looking for a Vendor Qualification Associate I, who will report to the Director of Vendor Outsourcing.

• The candidate will be responsible for ensuring high quality of data and services across all vendors supporting Client’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.
• Daily activities will include, but are not limited to, conducting Request for Information (RFI), Data Privacy and Security IT Assessments, Anti-Bribery and Anti-Corruption Due Diligence, Financial Health Assessments, Inspection Readiness Preparation Activities, Data Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement Initiatives, Presentations, and Trainings.

Education Level

• BS or BA with 5 years of relevant experience.
• PMP certification or equivalent certification

Experience

• The candidate should have executive presence, excellent communication skills, project management & critical thinking skills; and is comfortable interacting with internal stakeholders and external vendors.
• The Vendor Qualification Associate II will be regularly partnering with team members such as R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and vendors.
• 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 10+ years of relevant experience in the pharmaceutical or biopharmaceutical industry.
• Candidates can be current or former project managers & Project management experience in Pharmaceutical or Healthcare industries.