Senior Site Contracts Associate, IQVIA Biotech

IQVIA•Durham, NC

About The Position

IQVIA Biotech is seeking a Sr. Site Contracts Associate or Site Contracts Associate with 3-5 years of experience in negotiating clinical site contracts and budget templates. This role requires candidates with sponsor-facing experience. IQVIA Biotech is a full-service CRO dedicated to serving biotech sponsors, offering agile, therapeutically aligned solutions and trusted partnerships to accelerate the delivery of breakthrough treatments to patients. The role involves developing global contracting strategies and supporting all required start-up contracting activities for selected sponsors, studies, or multi-protocol programs based on sponsor requirements.

Requirements

Bachelor's Degree Related field.
3-5-year relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience acting as a contract negotiator.
Equivalent combination of education, training and experience.
Good negotiating and communication skills with ability to challenge.
Strong legal, financial and/or technical writing skills.
Strong 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.
Good understanding of clinical trial contract management.
Ability to develop and suggest alternate contracting language, terms, and financial options.

Responsibilities

Develop the global contracting strategy and 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.
Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.
Develop contract language, payment language and budget templates as required as applicable to the position.
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 as applicable to the position, 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 clinical trials, whilst enabling compliance with regulatory requirements.
Assist with 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 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 as required.