Senior Site Contracts Associate

About the role

IQVIA Biotech, a full-service CRO serving biotech sponsors, is hiring a Senior Site Contracts Associate in Mexico City. The role develops the global contracting strategy and supports the delivery of start-up contracting activities for selected sponsors, studies or multi-protocol programs, and requires about 5 years of experience negotiating clinical site contracts and budget templates, with CRO, pharma or sponsor experience.

Key responsibilities

• Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support proposal development.
• Develop contract language, payment language and budget templates as required.
• Maintain contracting systems, tools, processes and training materials in line with the Scope of Work and Project Plan.
• Collaborate with sponsors, stakeholders and RSU regions and countries to deliver the agreed project scope.
• Provide specialist legal, operational and financial contracting support to Study Teams on site agreements, while ensuring compliance with regulatory requirements.
• Assist with creating and reviewing core scientific, technical and administrative documentation for study initiation and maintenance.
• Contribute to collecting, interpreting and sharing contracting intelligence for assigned studies and the wider company.
• Ensure contracting efficiency, adherence to project timelines and financial goals, and report performance metrics and out-of-scope activities.
• Work with Quality Management on contract management and quality standards, and mentor and coach colleagues, including delivering training materials.

Required profile

• Bachelor's degree in a related field, or equivalent combination of education, training and experience.
• 3-5 years of relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience as a contract negotiator.
• Good negotiating and communication skills with the ability to challenge.
• Strong legal, financial and/or technical writing skills.
• Good understanding of clinical trial contract management and ability to suggest alternative contracting language, terms and financial options.

Required skills

• Knowledge of the regulated clinical trial environment and the drug development process.
• Ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of regulatory requirements, SOPs and corporate standards.