GLOBAL SR. SITE CONTRACTS ASSOCIATE

Manage the contract strategy and support delivery of all required start-up contracting activities for selected sponsors and for complex studies or multi-protocol programs as determined by the Sponsor's requirements.
May include line management responsibilities.
Essential Functions • Responsible for the development of complex investigator grant estimates, contracting strategies, coordination of investigator grants, as applicable and proposal text to support the proposal development process.
• Develop contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors and complex studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy, as applicable to the position.
• 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, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of complex clinical trials, whilst ensuring compliance with regulatory requirements and local laws.
• Create, publish and\/or review core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Assess and review the contracting landscape and 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, and provide technical guidance both within and outside the project.
• Deliver presentations to clients and professional bodies as required.
• As applicable, ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
• Take a lead role in developing long standing relationships with preferred IQVIA clients\/customers • may serve as a liaison for non-specific projects for top clients\/customers.
Qualifications • Bachelor's Degree Related field Req • Fluency in Italian • Relevant sponsor or clincial research organization clincial site contracting experience, including demonstrable experience acting as an international contract expert.
• Good negotiating and communication skills with ability to challenge.
• Excellent legal, financial and\/or technical writing skills.
• Thorough 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.
• Strong knowledge of Microsoft Office and e-mail, Word and Excel applications.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
Learn more at https.
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