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A leading company in clinical research services, based in Reading, seeks a Site Contract Associate with expertise in managing contracting activities for complex studies. The role requires a Bachelor's degree and relevant experience in contract negotiation and project management, offering an opportunity to impact clinical trials positively.
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Job Overview
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 Sponsors requirements. May include line management responsibilities.
Job Overview
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 Sponsors 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
4 to 7 years relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable experience acting as an international contract expert.
Good negotiating and communication skills with ability to challenge..
Thorough understanding of regulated clinical trial environment and knowledge of drug development process.
Proven ability to exercise independent judgment, taking calculated risks when making decisions.
Strong project leadership skills, with ability to motivate, coach and mentor.
Strong knowledge of clinical trial contract management.
Ability to work well within a matrix team environment.
Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Ability to utilize metrics and then communicate these with study team to establish timelines for deliverables.
Proven ability to take on a project or new initiative and grow the program to make an impact across departments.
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 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.
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