Contract Administrator
📋 Role Overview & Responsibilities
Responsibilities:Conduct functional internal audits on behalf of Vendor Outsourcing to ensure meticulous oversight of documentations, adherence to work procedures, and compliance standards.Assist in business process improvement initiatives to maximize quality and operational efficiencies within Vendor Outsourcing.Review Vendor Outsourcing's functional responsibilities throughout the vendor sourcing, contracting, and management processes, focusing on support for the clinical development portfolio.Lead functional internal audits of VO’s electronic Trial Master File (eTMF) and Contract Repositories, ensuring data integrity and compliance with regulatory requirements.Coach VO team members to resolve quality control issues and serve as the primary reviewer of QC data for inspection readiness.Manage tasks and projects under minimal supervision, demonstrating the ability to prioritize effectively and proficiently.
Qualifications:Minimum of 5 years of relevant experience in the pharmaceutical or biopharmaceutical industry.Bachelor's degree (BS or BA) required.PMP certification or equivalent certification preferred.Experience as a current or former project manager in the pharmaceutical or healthcare industries desirable.Thorough understanding of Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and ICH E6 R2 compliance requirements.Familiarity with global and regional trends in compliance.Strong interpersonal communication skills, with the ability to interact effectively with internal stakeholders and external vendors.Exceptional attention to detail and proactive management of quality findings.Strong project management, organization, and critical thinking skills.Executive presence and ability to thrive in a dynamic work environment.
Top 3 Required Skill Sets:Vendor OutsourcingProject management experience in Pharmaceutical or Healthcare industriesDeep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries
Top 3 Nice-to-Have Skill Sets:Quality and Compliance expertiseVendor Contracting experienceR&D Clinical knowledge
Additional Requirements:Great attention to detailGrowth mindsetProactive leader to drive initiativesStrong written and verbal communication skillsPassionate about the pharmaceutical industry
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This position is located in San Mateo, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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