Senior Site Contracts Associate

IQVIA LLC; Ciudad de México; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

IQVIA LLC in Mexico is seeking a Sr. Site Contracts Associate with 5 years of CRO/CRO-like experience negotiating clinical site contracts and budget templates. Experience with CRO, pharma, or sponsor environments is required.

The role focuses on developing global contracting strategy, supporting start-up contracting activities across sponsors and multi-protocol programs, and ensuring compliance with regulatory requirements through robust contract management.

Formación

• Bachelor's degree in a related field is required.
• 3–5 years of sponsor or CRO clinical site contracting experience with global/regional exposure.
• Strong negotiation and communication skills with the ability to challenge.
• Strong legal, financial and/or technical writing skills.
• Solid understanding of regulated clinical trial environments and drug development processes.
• Knowledge of GCP/ICH and regulatory guidelines.
• Familiarity with regulatory requirements and SOPs.

Responsabilidades

• Develop and coordinate the development of investigator grants and budget estimates to support proposals.
• Develop contract language, payment language, and budget templates as required.
• Use contracting systems and processes in line with project plans and strategies.
• Collaborate with sponsors, stakeholders, and RSU regions to deliver project scope on time and within budget.
• Provide legal, operational, and financial contracting support to study teams for site agreements.
• Assist in creating/reviewing core scientific, technical and administrative documentation for business development and study initiation.
• Disseminate contracting intelligence to support studies and the company.
• Ensure contracting efficiency and adherence to timelines and financial goals.
• Report contracting performance metrics and out-of-scope activities.
• Coordinate with Quality Management to ensure contract management and quality standards.
• Mentor colleagues and deliver training materials as required.

Conocimientos

Negotiation

Communication

Technical writing

Regulatory knowledge

Educación

Bachelor's degree in related field

Herramientas

Contracting systems

Budget templates

Descripción del empleo

Internal Job Description IQVIA Biotech is hiring for Sr. Site Contracts Associate in Mexico with 5 years experience negotiating clinical site contracts and budget templates. Must have CRO, Pharma, or Sponsor experience. IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Job Overview

Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements.

Essential Functions

• Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.
• Develop contract language, payment language and budget templates as required as applicable to the position
• Utilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
• Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
• Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Assist with the creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required.
• Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreements
• Report contracting performance metrics and out of scope contracting activities as required.
• Work with Quality Management to ensure appropriate contract management and quality standards.
• Mentor and coach colleagues as required including the delivery of training materials as required.

Qualifications

• Bachelor's Degree Related field.
• 3-5-year relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience acting as a contract negotiator. Equivalent combination of education, training and experience.
• Good negotiating and communication skills with ability to challenge.
• Strong legal, financial and/or technical writing skills.
• Strong understanding of regulated clinical trial environment and knowledge of drug development process.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards.
• Good understanding of clinical trial contract management.
• Ability to develop and suggest alternate contracting language, terms, and financial options.

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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.