Senior Site Contracts Associate

IQVIA LLC; São Paulo; Presencial; BRL 180 000 - 240 000; Tempo integral

Resumo da oferta

IQVIA Biotech in Brazil is seeking a Sr. Site Contracts Associate with 5 years of experience negotiating clinical site contracts and budgets.

You will develop the global contracting strategy and support start-up contracting activities for sponsors, studies, or multi-protocol programs as determined by sponsor requirements. This role requires strong negotiation, regulatory knowledge, and ability to draft and review contract language and budget templates while coordinating with sponsors, RSU

Qualificações

• Bachelor's degree in a related field.
• 3–5 years sponsor or CRO contracting experience, including global/regional exposure.
• Strong negotiation and communication skills with ability to challenge.
• Solid knowledge of GCP/ICH and regulatory guidelines.

Responsabilidades

• Develop and coordinate the creation of investigator grants and estimates, contracting strategies, and proposal text.
• Develop contract language, payment language, and budget templates as required.
• Utilize contracting systems, tools, processes, and training materials per project plan.
• Collaborate with sponsors, stakeholders, RSU regions and countries to deliver contracted scope.
• Provide specialist legal, operational, and financial contracting support to study teams.
• Create/review core scientific, technical, and administrative documents for study initiation and maintenance.
• Provide contracting insight to support studies and wider company needs.
• Ensure contracting efficiency and adherence to timelines and financial goals.
• Report contracting performance metrics and out-of-scope activities.
• Work with Quality Management to ensure contract management standards.
• Mentor and coach colleagues including training materials.

Conhecimentos

Negotiation skills

Communication skills

Legal writing

Financial writing

GCP/ICH knowledge

Contract management

Regulatory awareness

Formação académica

Bachelor's degree in related field

Ferramentas

Contracting systems

Budget templates

Descrição da oferta de emprego

IQVIA Biotech is hiring for Sr. Site Contracts Associate in Brazil with 5 years experience negotiating clinical site contracts and budget templates. 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.