Senior Clinical Research Vendor Specialist

Senior Clinical Research Vendor Specialist Hybrid: Onsite in Irvine, CA every T/TH/Every other Friday Job Summary: Under general direction, theSenior Clinical Research Vendor Specialistis 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 relationshipsand performance throughout the lifecycle of clinical trials. Oversee vendor compliancewith 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 meetingsand issue resolution. Ensure documentationof vendor oversight is audit ready. Collaborate with cross-functional teamsincluding Clinical Operations, Regulatory, Quality, and Finance. Contribute to protocol developmentand operational planning to ensure vendor alignment. Support vendor-related activitiesin post-market clinical follow-up (PMCF) and post-approval studies (PAS). Maintain awarenessof industry trends and best practices in vendor management. Mentor junior team membersor support training initiatives. Experience & Education: Education:Minimum of a bachelors 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.