Clinical Contracts Associate

VARITEFoster City, CA
Hybrid

About The Position

VARITE is looking for a qualified Vendor Qualification Associate I in Foster City, CA. The client is an American biopharmaceutical company focused on researching and developing antiviral drugs for HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19. VARITE, established in 2000, is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With over 850 global consultants, VARITE is committed to delivering excellence through comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services. This is a contract position for 12 months with a pay rate range of $40.00 - $42.73/hr on W2. The role requires the candidate to be a USC or GC. The position is on-site in Foster City, CA, with a hybrid work arrangement (3 days a week on-site).

Requirements

  • BS or BA with 5 years of relevant experience.
  • PMP certification or equivalent certification.
  • Executive presence.
  • Excellent communication skills.
  • Project management skills.
  • Critical thinking skills.
  • Comfortable interacting with internal stakeholders and external vendors.
  • 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.
  • 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.

Nice To Haves

  • 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.

Responsibilities

  • Ensuring high quality of data and services across all vendors supporting the company's global R&D portfolio – Ph I-IV clinical trials.
  • Leading and/or supporting cross-functional efforts in vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities.
  • Conducting Request for Information (RFI), Data Privacy and Security IT Assessments, Anti-Bribery and Anti-Corruption Due Diligence, Financial Health Assessments, and Inspection Readiness Preparation Activities.
  • Performing Data Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement Initiatives.
  • Preparing Presentations and Trainings.

Benefits

  • Health Insurance: Medical, dental, and vision coverage
  • Retirement Plans: Participation in a company-sponsored retirement savings plan.
  • Legal Service Plans: Offering access to attorneys for legal advice and representation.
  • Employee referral bonus
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