Contract Negotiator (Fsp) Italy
Contract Negotiator (FSP) Italy Job Overview
Support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor's requirements, including pre-award activities.
Essential Functions
Develop simple investigator grant estimates and proposal text to support the proposal development process.
Utilize and maintain contract and budget templates and 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, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Assist in 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; report contracting performance metrics and out of scope contracting activities as required.
Comply with contract management and quality standards. Provide administrative and operational support to investigator site contract analysts, managers and directors as required.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
Qualifications
Bachelor's Degree Req
1 year relevant experience, including demonstrable experience acting as a contract negotiator. Equivalent combination of education, training and experience. Req
Good negotiating and communication skills.
Understanding of regulated clinical trial environment and knowledge of drug development process.
Good understanding of clinical trial contract management.
Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
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