Description
IQVIA Biotech is seeking a Sr. Site Contracts Associate with 3-5 years of experience in negotiating clinical site contracts and budget templates. As a Sr. Site Contracts Associate, you will develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs.
Essential Functions:
- Develop and coordinate investigator grants and estimates, contracting strategies, and proposal text to support the proposal development process.
- Create contract language, payment language, and budget templates as required.
- Utilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs.
- Ensure collaboration 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.
- Assist with the creation and/or review of core scientific, technical, and administrative documentation.
- Contribute to the collection, interpretation, analysis, and dissemination of accurate contracting intelligence.
- Ensure overall contracting efficiency and adherence to project timelines and financial goals.
- Report contracting performance metrics and out of scope contracting activities.
- Work with Quality Management to ensure appropriate contract management and quality standards.
Qualifications:
- Bachelor's Degree in a related field.
- 3-5 years of relevant sponsor or clinical research organization clinical site contracting experience.
- Good negotiating and communication skills with the ability to challenge.
- Strong legal, financial, and/or technical writing skills.
- Strong understanding of the regulated clinical trial environment and knowledge of the drug development process.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.