Global Contract Strategist

hace 3 días

Madrid, Madrid, España Iqvia Argentina A tiempo completo
Job Overview

Develop and implement a comprehensive global contracting strategy to support the delivery of clinical trials and studies for selected sponsors. Collaborate with cross-functional teams to ensure timely and efficient contracting processes.

Key Responsibilities
  • 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.
  • 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.
  • 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 legal, operational, and financial contracting support to the Study Teams 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.
  • Contribute to the collection, interpretation, analysis, and dissemination of accurate contracting intelligence to support assigned studies and the wider company.
  • Ensure overall contracting efficiency and adherence to project timelines and financial goals.
  • 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.
  • Deliver presentations to clients as required.
  • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans.
Requirements
  • Bachelor's Degree in a related field required.
  • 5 years 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.
  • Good interpersonal skills and a strong team player.
  • 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.

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