Senior Site Contracts Associate

IQVIA LLC; São Paulo; Híbrido; BRL 120 000 - 210 000; Tempo integral

Resumo da oferta

IQVIA Biotech in Brazil is seeking a Sr. Site Contracts Associate with 5 years' experience negotiating clinical site contracts and budgets. You will support start-up contracting activities for sponsors, studies or multi-protocol programs, and help deliver the contracting strategy.

You will develop investigator grants and budget templates, draft contract and payment language, and ensure compliance with GCP/ICH and regulatory guidelines while coordinating with sponsors and RSU regions.

Qualificações

• Bachelor's degree in related field required.
• 3-5 years experience in sponsor or CRO site contracting, including global/regional experience.
• Strong negotiating and communication skills.
• Knowledge of GCP/ICH and regulatory guidelines.
• Understanding of clinical trial contract management.

Responsabilidades

• Develop global contracting strategy for selected sponsors, studies or multi-protocol programs.
• Develop investigator grants and budget templates; draft contract language.
• Maintain contracting systems and training materials.
• Collaborate with sponsors, stakeholders and RSU regions to meet project scope and timelines.
• Provide legal, operational and financial contracting support to Study Teams.
• Review core documentation to support study initiation and maintenance.
• Deliver contracting intelligence and insights for assigned studies.

Conhecimentos

Negotiation & communication

Legal/financial writing

GCP/ICH knowledge

Clinical trial understanding

Contract management

Formação académica

Bachelor's Degree Related field

3-5 years site contracting experience

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.