Duration: 12 months, with the possibility of a 6-month extension
Job Overview:
We are seeking a highly organized and detail-oriented Vendor Qualification Associate I to join our team. The successful candidate will be responsible for ensuring high-quality data and services across all vendors supporting our global R&D portfolio, particularly in Phase I-IV clinical trials. This role will require an individual with strong experience in vendor capability assessments, procurement, compliance, and project management within the pharmaceutical or biopharmaceutical industry.
Key Responsibilities:
Vendor Qualification & Assessment:
· Lead and support Request for Information (RFI) processes to evaluate potential vendors.
· Conduct Data Privacy & Security IT Assessments, Anti-Bribery and Anti-Corruption Due Diligence, and Financial Health Assessments to ensure vendor compliance with company standards.
· Manage the Vendor Subcontractor Process to ensure all parties involved meet expectations and contractual agreements.
Clinical Trial Support:
· Collaborate with cross-functional teams to ensure vendor services align with the needs of clinical trials across areas such as clinical monitoring, data management, biostatistics, medical writing, wearables, telemedicine, real-world evidence (RWD/RWE), and more.
· Support inspection readiness activities to ensure compliance with GxP standards and regulatory requirements.
Project Management & Data Analysis:
· Conduct data analyses and benchmarking activities to derive insights and inform vendor strategy and continuous improvement initiatives.
· Create and deliver presentations and training to internal stakeholders and external vendors as needed.
· Manage multiple competing priorities, ensuring timely completion of tasks with minimal supervision.
Stakeholder Collaboration:
· Partner with key internal stakeholders including R&D Quality & Compliance, Clinical Operations, Finance, Legal, Business Conduct, Vendor Relationship Management, and other cross-functional teams.
· Foster and maintain strong relationships with external vendors, ensuring alignment on project goals, timelines, and quality standards.
Compliance & Regulatory Expertise:
· Ensure that all vendor activities comply with Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and ICH E6 R2 guidelines.
· Stay updated on global and regional regulatory trends to ensure ongoing compliance.
Education:
· BS or BA degree is required (a related field such as life sciences, business, or healthcare preferred).
Experience:
· A minimum of 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry, ideally with experience in vendor management, clinical trial outsourcing, or clinical operations.
· Strong understanding of clinical trial activities (e.g., clinical monitoring, data management, medical writing, biomarker labs, etc.), and familiarity with associated technologies like wearables, telemedicine, and RWD/RWE.
Certifications:
· PMP (Project Management Professional) certification or equivalent is a plus, though not mandatory.
Skills:
· Strong project management skills, with the ability to manage multiple projects and prioritize effectively.
· Excellent communication and presentation skills, with the ability to interact confidently with both internal stakeholders and external vendors.
· Proficiency in Excel (a test will be required).
· Solid understanding of GxP (Good Clinical Practice, Good Laboratory Practice, etc.) and regulatory compliance in clinical trials.
· Critical thinking, problem-solving, and the ability to drive continuous improvement initiatives.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Shivani
Email: shivani.trika@ustechsolutionsinc.com
Internal Id: 24-25620
