Sr. Site Contracts Associate/Site Contracts Associate, U.S. - IQVIA Biotech

IQVIA; Wayne (PA); On-site; USD 47,000 - 158,000; Full time

Job summary

IQVIA is hiring for Sr. Site Contracts Associate or Site Contracts Associate in Wayne, PA. The role involves developing global contracting strategies and managing site contracts and budgets, requiring robust negotiation skills and relevant experience in clinical contracting. This position is essential in overseeing contractual compliance within clinical trials and contributing to efficient business processes.

Qualifications

• 3-5 years of clinical site contracting experience for Sr. level.
• 1-3 years for Site Contracts Associate level.
• Ability to apply GCP/ICH and applicable regulatory guidelines.

Responsibilities

• Negotiate clinical site contracts and budget templates.
• Develop grant plans and contracting strategies.
• Collaborate with stakeholders and maintain project timelines.

Skills

Negotiating

Communication

Legal knowledge

Financial skills

Technical writing

Understanding of clinical trial environment

Education

Bachelor's Degree in related field

Job description

IQVIA Biotech is hiring for Sr. Site Contracts Associate or Site Contracts Associate with experience negotiating clinical site contracts and budget templates. Grant Plan a plus. 3-5 years’ experience for Senior level and 1-3 years at the Site Contract Associate level:

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 athttps://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

The potential base pay range for this role, when annualized, is $47,400.00 - $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.