Senior Clinical Research Vendor Specialist

Hybrid: Onsite in Irvine, CA every T/TH/Every other Friday

Job Summary:

Under general direction, the Senior Clinical Research Vendor Specialist is responsible for the oversight and coordination of external vendors supporting one or several clinical trials within the Clinical R&D Department. This role ensures vendor performance aligns with study timelines, regulatory requirements, and budget expectations, while fostering strong partnerships across internal teams and external collaborators.

Duties & Responsibilities:

• Lead vendor selection, qualification, and contracting processes for clinical studies (e.g., CROs, labs, imaging, eCOA, IRT).
  

• Manage vendor relationships and performance throughout the lifecycle of clinical trials.
  

• Oversee vendor compliance with study protocols, GCP, and regulatory requirements.
  

• Coordinate RFPs, bid defenses, and contract negotiations in collaboration with Procurement and Legal.
  

• Monitor vendor deliverables, timelines, and key performance indicators (KPIs).
  

• Support budget development, payment processing, and financial tracking related to vendor activities.
  

• Facilitate regular vendor meetings and issue resolution.
  

• Ensure documentation of vendor oversight is audit ready.
  

• Collaborate with cross-functional teams including Clinical Operations, Regulatory, Quality, and Finance.
  

• Contribute to protocol development and operational planning to ensure vendor alignment.
  

• Support vendor-related activities in post-market clinical follow-up (PMCF) and post-approval studies (PAS).
  

• Maintain awareness of industry trends and best practices in vendor management.
  

• Mentor junior team members or support training initiatives.

Experience & Education:

• Education: Minimum of a bachelor’s degree in Life Sciences, Healthcare, or related field required. Advanced degree (MS, MBA) preferred.
  

• Clinical Experience: BS with at least 5 years, or MS with at least 3 years of relevant clinical research experience.
  

• Vendor Management: Minimum 2 years of direct vendor management experience in clinical trials.
  

• Industry: Experience in the medical device industry is highly preferred.
  

• Regulatory Knowledge: Familiarity with GCP, ISO 14155, and FDA regulations required.
  

• Certifications: Relevant certifications (e.g., CCRA, CCRP, PMP) are a plus.

Required Knowledge, Skills & Abilities:

• Strong understanding of clinical trial operations and vendor oversight.
  

• Proven ability to manage multiple vendors and complex projects.
  

• Excellent negotiation, communication, and organizational skills.
  

• Proficiency in clinical trial management systems and Microsoft Office tools.
  

• Ability to lead small study teams to deliver critical milestones.
  

• Leadership Qualities: Ability to develop collaborative relationships, participate in process improvement, and ensure all deliverables are met on time and within budget.

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