The Vendor Operations Lead is responsible for the creation, implementation, and management of systems, processes, and training in support of all vendor management operational activities. Drives consistency by ensuring standards are developed and followed. Drives participation and input from contacts in Country Organizations and key stakeholders to ensure understanding and adherence to systems, processes, and training.
All Vendor Operation Leads will be responsible to support the operations by performing the following:
- Drive and coordinate the creation of sponsor standards and guidelines with support from team members
- Ensure implementation of standards, templates, tools, and processes for vendor risk assessment & selection
- Drive consistency and compliance with SOPs to ensure supplier documentation and assessments are accurate and compliant with current regulations and quality modules
- Experience with audits including development of plans, analyzing findings, and ensuring the appropriate corrective actions are put in place and completed.
- Lead the creation of standard templates (ex. charters, quality plans/agreements, trackers, reports, communication tools, etc) and any maintenance to support consistency and compliance with SOPs, governance, and operations.
- Function as a subject matter expert for assessing any new process or standard needs for third-party compliance and risk management
- Identify compliance and quality trends in collaboration with External Relationship Management Team (ERMT) assess opportunities to improve process performance with key third parties.
- Participate in continuous process improvement and harmonization across vendor team, key stakeholders, and Country organizations to ensure compliance with all sponsor policies and procedures
- Represent the vendor team to review and contribute to processes in other units which impact third party operations.
- Support vendor team and Country Organization with standardization of operation third-party management activities in support of inspections, audits, analytics and new processes
- Partner closely with global quality and local country contacts to ensure SOPs/Working Practices are in place for global and trial level third party management and timely training and adherence is maintained within vendor teams, Country Organizations and cross-functionally, as required.
- Ensure vendor team procedures align with Global and Local policies, Systems and Processes
- Collaboration with Country Organization and key stakeholders ( to ensure robust processes are defined and in place for third party management
- Liaise with regulatory and quality to ensure any new regulations are documented in processes and ensure high quality performance from third parties
Business University degree preferred or equivalent experience
Fluent English (oral and written)
10+ years working experience and excellent knowledge of the clinical operation processes, systems, regulatory requirements, and third party management related activities
Excellent knowledge of GxP and ICH regulations
Strong knowledge of clinical trial design and mapping to third party requirements
Operational excellence within a global organization
Demonstrated partnering across divisions with internal and external stakeholders
History of successfully working in a cross-functional global team and proven ability to function in matrix structure organization
Leadership to deliver projects according to required deliverables and timelines
Quality mind-set and detail-oriented to meet or exceed regulatory requirements
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-statusApply Now