Senior Site Contract Associate - Iqvia Biotech - Remote

IQVIA Biotech; Viseu; Remote; EUR 55,000 - 75,000; Full time

Job summary

IQVIA Biotech is seeking a Senior Site Contracts Associate to support start-up contracting activities for sponsors and studies across France, Spain, Portugal and Greece. This homebased role requires coordinating with sponsors, RSU regions and countries to deliver contracted scope on time and within budget.

You will develop simple investigator grant estimates, maintain CTMS and contracting systems, review core documents, and help ensure regulatory compliance and high-quality contract management

Qualifications

• Bachelor's Degree in life sciences or health care.
• +6 years relevant experience, including demonstrable experience acting as a contract negotiator.
• Relevant sponsor or clinical research organization clinical site contracting experience.
• Good negotiating and communication skills.
• Good interpersonal skills and a strong team player.
• Strong technical writing skills.
• 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 organizational and planning skills.
• Strong knowledge of Microsoft Office and e-mail applications.
• Ability to interpret pricing models and to prepare proposals, bid grids and budgets.
• Good understanding of clinical trial contract management.
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

Responsibilities

• Develop simple investigator grant estimates and proposal text to support the proposal development process.
• Utilize and maintain contract and budget templates and 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, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
• Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Assist in 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; report contracting performance metrics and out of scope contracting activities as required.
• Comply with contract management and quality standards. Provide administrative and operational support to investigator site contract analysts, managers and directors as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.

Skills

Contract negotiation

Clinical contracts

Regulatory understanding

GCP/ICH knowledge

Communication skills

Team player

Technical writing

Budgeting

Microsoft Office

Proposal/budgeting

Education

Bachelor's Degree in life sciences

Tools

CTMS

Contract management systems

Microsoft Office

Job description

Senior Site Contracts Associate IQVIA Biotech France, Spain, Portugal & Greece

- Homebased

IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.

IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.

Job Overview Support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor's requirements, including pre-award activities.

Essential Functions

• Develop simple investigator grant estimates and proposal text to support the proposal development process.
• Utilize and maintain contract and budget templates and 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, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
• Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Assist in 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; report contracting performance metrics and out of scope contracting activities as required.
• Comply with contract management and quality standards. Provide administrative and operational support to investigator site contract analysts, managers and directors as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.

Qualifications And Skills

• Bachelor's Degree in life sciences or health care
• +6 years relevant experience, including demonstrable experience acting as a contract negotiator.
• Relevant sponsor or clinical research organization clinical site contracting experience.
• Good negotiating and communication skills.
• Good interpersonal skills and a strong team player.
• Strong technical writing skills.
• 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 organizational and planning skills.
• Strong knowledge of Microsoft Office and e-mail applications.
• Ability to interpret pricing models and to prepare proposals, bid grids and budgets.
• Good understanding of clinical trial contract management.
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

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.