Senior Site Contracts Associate, IQVIA Biotech

IQVIA•Durham, NC
•$49,200 - $157,100

About The Position

IQVIA Biotech is seeking a Senior Site Contracts Associate or Site Contracts Associate with 3–5 years of experience negotiating clinical site contracts and budget templates, as well as sponsor-facing experience. The role develops global contracting strategy and supports delivery of required start-up contracting activities for selected sponsors, studies, or multi-protocol programs based on sponsor requirements. The position develops investigator grants and estimates, contracting strategies, proposal text, contract and payment language, and budget templates. It maintains contracting systems, tools, processes, and training materials; collaborates with sponsors, stakeholders, and regional and country teams; and provides legal, operational, and financial contracting support to study teams. The role also supports study documentation and contracting intelligence, monitors efficiency, timelines, and financial goals, reports performance metrics and out-of-scope activities, and works with Quality Management to uphold contract management and quality standards. Mentoring colleagues and delivering training may also be required.

Requirements

  • Bachelor’s degree in a related field, or an equivalent combination of education, training, and experience.
  • 3–5 years of relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience acting as a contract negotiator.
  • Sponsor-facing experience.
  • Experience negotiating clinical site contracts and budget templates.
  • Good negotiating and communication skills, with the ability to challenge.
  • Strong legal, financial, and/or technical writing skills.
  • Strong understanding of the regulated clinical trial environment and knowledge of the drug development process.
  • Knowledge of and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, SOPs, and company Corporate Standards.
  • Good understanding of clinical trial contract management.
  • Ability to develop and suggest alternate contracting language, terms, and financial options.

Responsibilities

  • Develop and coordinate investigator grants and estimates, contracting strategies, and proposal text to support proposal development.
  • Develop contract language, payment language, and budget templates as applicable to the position.
  • Use and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies, or multi-protocol programs, in line with the Scope of Work, Project Plan, and agreed project strategy.
  • Collaborate and communicate with sponsors, stakeholders, and RSU regions and countries as applicable to 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 study teams for site agreements, facilitating business development and clinical trial initiation and maintenance while enabling regulatory compliance.
  • Assist with creating and/or reviewing core scientific, technical, and administrative documentation to support business development and study initiation and maintenance.
  • Contribute to collecting, interpreting, analyzing, and disseminating accurate contracting intelligence for assigned studies and the wider company.
  • Ensure contracting efficiency and adherence to project timelines and financial goals for 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 and deliver training materials as required.

Benefits

  • Health and welfare benefits may be offered, depending on the position.
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