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Job Description

Investigator Site Contracts Specialist

ルーマニア R1457467

ルーマニア| ルーマニア| Remote

今すぐ応募

Job Description

IQVIA is hiring for one of our sponsors a Investigator Site Contract Support to manage the contract strategy and support delivery of all required start-up contracting activities and for complex studies or multi-protocol programs as determined by the Sponsor’s requirements. 

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

Your Profile

  • Bachelor's Degree or Master Degree in Lifesciences, Law o related fied.
  • At least 5 years’ relevant sponsor or clincial research organization clinical site contracting experience, including demonstrable experience acting as an international contract expert.
  • Excellent legal, financial and/or technical writing skills.
  • Proficient level of English and Romania Language. Romania based. Good negotiating and communication skills with ability to challenge.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines in country and UE level. Strong knowledge of clinical trial contract management.
  • Regular user of Microsoft Office tools
  • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

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

今すぐ応募

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