Site Activation Specialist- Contract Negotiator

IQVIA•Durham, NC

1d•$49,200 - $123,000

About The Position

Support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements. Complete and negotiate standard investigator site contracts and budgets (IQVIA or Client developed) for various clients. May be required to adapt contract and budget templates for sites. 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, 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 Site Activation plan. Provide specialist legal, operational and financial contracting support 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 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. Work with Quality Management to ensure appropriate contract management and quality standards. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans. May be required to deliver presentations to clients as required.

Requirements

Bachelor's Degree
2-3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.

Responsibilities

Complete and negotiate standard investigator site contracts and budgets (IQVIA or Client developed) for various clients.
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, 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 Site Activation plan.
Provide specialist legal, operational and financial contracting support 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 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.
Work with Quality Management to ensure appropriate contract management and quality standards.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
May be required to deliver presentations to clients as required.