Clinical contracts associate

2 weeks ago


Foster City, United States Net2Source Inc. Full time

Position: Clinical Contracts Associate - II*

Location: Foster city, CA

Duration: 12+ Months (Extendable) Projected for 12 months and beyond depending on the business need.


This Position is Remote

Pay Rate: $41.00/hr on W2


Client: Pharma


Benefits:401K, Paid-Time Off are NOT offered (except where state applicable sick time is required)

Shift Time: (Normal Business hours Mon – Friday PST.)


Job Description:

Description

TRUE JOB TITLE: Vendor Qualification Associate I


Location: Candidates can work onsite from Foster City, CA or Santa Monica, CA, Seattle


Contract Duration: 12 months with possible 6 months extension


Description

Gilead 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.


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, Vendor Subcontractor Process Management, 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.


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 I 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 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


Intake Notes:


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


Top 3 Nice to Have Skill Sets: (1) Vendor Qualification, (2) Vendor Outsourcing & (3) Vendor Contracting


Required Degree or Certification: BS or BA


No BS or BA is a Disqualifier


*Suppliers, Please Note: Attach the results along with the resume, or send to Sabrina Grech



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