Senior Site Contracts Associate

IQVIA; Mexico; On-site; MXN 400,000 - 600,000; Full time

Job summary

IQVIA Biotech, a full-service CRO, seeks a Sr. Site Contracts Associate in Mexico to develop contracting strategies and support start-up activities for selected sponsors and multi-protocol programs.

Required: 5 years negotiating site contracts, strong negotiation, legal writing and budgeting skills, plus knowledge of GCP/ICH and regulatory guidelines. Experience with CROs, pharma, or sponsors is preferred.

Qualifications

• 5 years of experience negotiating clinical site contracts and budget templates.
• Good negotiating and communication skills with ability to challenge.
• Strong legal, financial and/or technical writing skills.
• Knowledge of GCP/ICH and regulatory guidelines.

Responsibilities

• Develop contracting strategy and support start-up contracting activities.
• Create and review core contracting documents, language and budgets.
• Maintain contracting systems and training materials for projects.
• Collaborate with sponsors, RSU regions and countries to deliver scope.

Skills

Contract negotiation

Communication skills

Legal writing

Education

Bachelor's Degree Related field

Tools

Contracting systems

Job description

IQVIA Biotech is hiring for Sr. Site Contracts Associate in Mexico

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.