Senior Site Contracts Associate, IQVIA Biotech

IQVIA; Durham (NC); On-site; USD 49,000 - 157,000; Full time

Job summary

IQVIA Biotech invites applications for Sr. Site Contracts Associate or Site Contracts Associate with 3–5 years of experience in negotiating clinical site contracts and budget templates.

This role demands sponsor-facing experience and a strong grasp of regulatory guidelines, ensuring compliant, timely contracting across studies. We offer a full-service CRO environment with global collaboration and opportunities to impact trial startups, from proposal development to site initiation, with a focus

Qualifications

• Bachelor's degree in related field is required.
• 3–5 years of sponsor or CRO clinical site contracting experience.
• Strong negotiating and communication skills are essential.
• Knowledge of regulated clinical trial environment and drug development process.
• Experience with GCP/ICH and regulatory guidelines is required.
• Familiarity with clinical trial contract management and SOPs.

Responsibilities

• Develop contracting strategy and support start-up contracting for sponsors, studies or multi-protocol programs.
• Coordinate development of investigator grants, estimates, contracting strategies and proposal text.
• Develop contract language, payment language and budget templates as required.
• Maintain contracting systems, tools, and training materials per project plan.
• Collaborate with sponsors, stakeholders and RSU regions to deliver project scope on time and within requirements.
• Provide specialist legal, operational and financial contracting support to study teams.

Skills

Negotiation

Communication

Legal writing

Financial writing

GCP/ICH knowledge

Education

Bachelor's Degree in Related field

Job description

IQVIA Biotech is seeking Sr. Site Contracts Associate or Site Contracts Associate with 3-5 years' experience negotiating clinical site contracts and budget templates. This role requires candidates who have sponsor facing experience as well.

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

https://jobs.iqvia.com/eoe

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.

The potential base pay range for this role, when annualized, is $49,200.00 - $157,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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.