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Clinical Contract Associate

5+ years
$35/hr - $41/hr
10 Feb. 18, 2025
Job Description
Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Contracts Associate
Location: Foster City, CA
Job Type: Contract
Pay Rate: $35/hr - $41/hr
Duration: 12+ Months (Extendable)
Hybrid

Job Description
We are seeking a Vendor Qualification Associate I to join our team and report to the Senior Manager of Vendor Outsourcing. This position is responsible for ensuring the high quality of data and services across all vendors supporting global R&D, specifically for Ph I-IV clinical trials. The ideal candidate will have experience in vendor capability assessments, sourcing, contracting, procurement, and inspection readiness activities, with an understanding of various clinical trial functions.

Key Responsibilities

  • Lead/support vendor qualification efforts, including RFI, IT assessments, due diligence, and financial health assessments.
  • Prepare for inspection readiness and continuous improvement initiatives.
  • Perform data analyses and benchmarking to inform strategies.
  • Partner with cross-functional teams such as R&D Quality & Compliance, clinical operations, finance, legal, business conduct, and vendors.
  • Manage competing priorities with minimal supervision while maintaining effective communication.
  • Demonstrate knowledge of GCP, GVP, GLP, GDP, and ICH E6 R2 compliance requirements.
  • Conduct presentations and training as needed.

Required Skills

  • Executive presence with excellent communication, project management, and critical thinking skills.
  • Strong understanding of global and regional compliance trends.
  • Experience with vendor subcontractor process management and financial health assessments.
  • Ability to manage multiple priorities effectively.
  • Knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), and ICH E6 R2 compliance.
  • Familiarity with various clinical trial activities including clinical monitoring, data management, and Real World Data/Evidence (RWD/RWE).

Required Experience

  • 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry.
  • A BS or BA degree.
  • PMP certification or equivalent is a plus.
  • Project management experience in the pharmaceutical or healthcare industries.