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 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 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
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
By applying, you acknowledge that AI-assisted tools may be used during hiring.
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Numbers & Facts
Location
Foster City, CA
Skills
Benchmarkingunmatched
Biomarkersunmatched
Biostatisticsunmatched
Biotech and Pharmaceuticalunmatched
Category Managementunmatched
Clinical Data Managementunmatched
Clinical Monitoringunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Computer Securityunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Data Qualityunmatched
Due Diligenceunmatched
Equal Credit Opportunity Act (ECOA)unmatched
Equipment Maintenance/Repairunmatched
Financeunmatched
Financial Analysisunmatched
GCP (Good Clinical Practices)unmatched
Healthcareunmatched
Information/Data Security (InfoSec)unmatched
Informed Consentunmatched
Legalunmatched
Medical Imagingunmatched
Medical Writingunmatched
Outsourcingunmatched
Pharmacovigilanceunmatched
Privacy Controlsunmatched
Procurement Managementunmatched
Project/Program Managementunmatched
QoS (Quality of Service)unmatched
R Programming Languageunmatched
Request for Information (RFI)unmatched
Research & Development (R&D)unmatched
Security Analysisunmatched
Supplier Relationship Management (SRM)unmatched
Telemedicineunmatched
Training/Teachingunmatched
Vendor/Supplier Relationsunmatched
Wearablesunmatched
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