Job Overview
Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
The Contract Specialist is responsible for independently managing the preparation, review, and negotiation of clinical site agreements in support of study start-up activities. This role contributes directly to achieving study timelines by ensuring efficient contract execution while maintaining compliance with applicable regulations, sponsor requirements, and internal policies.
Essential Functions
Independently draft, review, and negotiate standard clinical trial agreements (e.g., CTAs, CDAs, amendments) with investigative sites and institutions.
Manage assigned contract portfolio to support site activation deliverables and study timelines.
Act as a primary point of contact for sites and internal teams for contract-related matters, ensuring clear and timely communication.
Apply approved negotiation parameters and escalate non-standard terms or higher-risk issues to senior team members or Legal as needed.
Collaborate with cross-functional stakeholders (e.g., Site Activation, Clinical Operations, Finance) to align contract terms, including budget-related provisions.
Track contract progress and maintain accurate, up-to-date documentation in relevant systems and tools.
Identify and proactively address contract-related delays, working to resolve issues and minimize impact on study timelines.
Ensure all contracts comply with applicable regulatory requirements, sponsor guidelines, and company policies.
Support audit and inspection readiness by maintaining complete and accurate contract files.
Contribute to continuous process improvements aimed at enhancing contract cycle times and quality.
Manage multiple priorities simultaneously while meeting established timelines and quality expectations.
Provide regular status updates and metrics to stakeholders and project teams.
Qualifications
• Bachelor's degree.
• At least 2 years of experience in clinical research (CRO or pharma) supporting the contract and budget negotiation with sites: direct contract/BGT negotiation experience.
• Advanced level of English skills, you will be working in a team that will support sites in North America.
Home based role!
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.